Others titles

  • MedSun Adverse Events Reports
  • MD Medical Product Safety Network
  • Medical Devices Safety Network

Keywords

  • Medical Product Safety
  • Adverse Event Reporting Program
  • MedSun
  • MD Safety
  • MD Reporting

Medical Product Safety Network

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

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John Snow Labs Standard End User License Agreement

Last updated:January 20, 2021

This Standard End User License Agreement (“EULA”) applies to customers of John Snow Labs Inc. (as defined below), using any product of John Snow Labs Inc. on John Snow Labs Marketplace as defined below (hereinafter referred to “you”) and John Snow Labs Inc., a Delaware corporation (“John Snow Labs”, “we” or “us”).

By downloading, installing, and/or using (as applicable) any Product of John Snow Labs (as defined below), you automatically agree to be bound by, and use our Products in compliance with, this EULA. This EULA, together with additional terms and conditions and/or policies referenced herein or located on https://www.johnsnowlabs.com and/or conveyed to you by John Snow Labs, is a legally binding contract between you and John Snow Labs.

PLEASE READ THIS EULA CAREFULLY BEFORE PURCHASING, INSTALLING OR USING OUR PRODUCTS MADE AVAILABLE ON JOHN SNOW LABS MARKETPLACE.

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Subject to your compliance with this EULA, as well as any other applicable policies, John Snow Labs grants you non-exclusive, non-transferable, license to install, access to, modify, and use of, the Products worldwide (subject to applicable export laws) during the term of this EULA (as described below) solely for research, private study and personal use of Products.

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Except for the foregoing license, you have no other rights in the Products and you may not modify, edit, copy, reproduce, create derivative works of, reverse engineer, alter, enhance or in any way exploit the Products in any manner. If you breach any of this EULA, the above license will terminate automatically.

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You will access or use our Products solely via John Snow Labs Data Library.

Except as otherwise explicitly provided in this EULA or as may be expressly permitted by applicable law, you will not, and will not permit or authorize any third party to:

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Your use of the Products is subject to our fees. All fees are given on our website https://www.johnsnowlabs.com. Except as set forth in this EULA, the fees are non-refundable. We are entitled to revise our fees from time to time.

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Term and Termination

This EULA will become effective as of the date of your order of Products and shall be in effect until terminated.

John Snow Labs may suspend or terminate your right to use our Products, if you or your end user’s use of the Products:

  1. is in breach of this EULA;
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  5. could be fraudulent.

We may also suspend or terminate your right to use our Products, if you fail to perform your payment obligations, or you have ceased to operate in the ordinary course, made an assignment for the benefit of creditors or similar disposition of your assets, or become the subject of any bankruptcy, reorganization, liquidation, dissolution or similar proceeding.

We may also suspend or terminate your right to use our Products without any reason upon a relevant 30 days’ written notice to you and will refund the unused fees pre-paid by you for access to the Products for the affected time period (if any). Where your access is suspended or terminated by the breach of this EULA or applicable laws, John Snow Labs will will not provide, or be liable for, any refund.

You will cease use of the Products during any period of suspension, or upon termination of this EULA.

All provisions which by their nature are intended to survive termination shall survive termination of this EULA.

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If applicable to your Product, John Snow Labs will provide you with the support services. If you use a trial access, support services are excluded. Under this EULA, our support services exclude any installation, training, maintenance services (including any error corrections, bug fixes, or new releases), technical assistance, consulting services, or other services of any kind. Such services are provided at John Snow Labs’ discretion.

From time to time John Snow Labs can perform updates to our software. If available, such updates may include bug fixes, new features and/or enhancements. You are solely responsible for deploying such updates at your own risk and liability.

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We do not provide you with the equipment to access our Products. You are responsible for all fees charged by third parties related to your access and use of our Products (e.g., charges by Internet service providers).

You are responsible for monitoring your use of the Products, including payment of all fees and/or taxes related to such access and use. You agree that John Snow Labs is permitted to request and you hereby consent to provide John Snow Labs information related to your use of the Products for auditing purposes.

You also certify that you are legally permitted to use the Products, and take full responsibility for the selection and use of the Products. This EULA is void where prohibited by law, and the right to use the Products is revoked in such jurisdictions. John Snow Labs makes no claim that the Products may be lawfully used outside of the United States. If you use the Products from outside of the United States, you do so at your own risk and you are responsible for compliance with the laws of jurisdiction.

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We may collect, store and receive personal and other information about you through our Products. Our collection and use of this information is governed by our Privacy Policy available at https://www.JohnSnowLabs.com/privacy/ which may be amended from time to time.

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Our Products may display, or contain links to, third party products, services, and websites. Any opinions, advice, statements, services, offers, or other information that constitutes part of the content expressed, authored, or made available by other users or other third parties, or which is accessible through or may be located using our Products (collectively, “Third Party Content”) are those of the respective authors or producers and not of us or our shareholders, directors, officers, employees, agents, or representatives.

We do not control Third Party Content and do not guarantee the accuracy, integrity or quality of such Third Party Content. We are not responsible for the performance of, we do not endorse, and we are not responsible or liable for, any Third Party Content or any information or materials advertised in any Third Party Content. By using our Products, you may be exposed to content that is offensive, indecent, or objectionable. We are not responsible or liable, directly or indirectly, for any damage or loss caused to you by your use of or reliance on any goods, services, or information available on or through any third party service or Third Party Content. It is your responsibility to evaluate the information, opinion, advice, or other content available on and through our Products.

Proprietary Rights

John Snow Labs will not obtain any rights under this EULA from you (or your licensors) to your content.

The Products, including software, is and remains the exclusive property of John Snow Labs and its licensors. Except for the access and use rights expressly set forth in this EULA, no license or other rights in or to the Products or John Snow Labs trademark(s) and other intellectual property rights therein, are granted to you, and all such licenses and rights are expressly reserved. You will not remove, alter, or obscure any proprietary notices (including copyright and trademark notices) on any portion of our Products or any Content.

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“John Snow Labs,” the John Snow Labs logo, and any other product, business or service name or slogan, whether registered or pending, displayed on our Products are trademarks of John Snow Labs, Inc. or its suppliers or licensors, and may not be copied, imitated or used, in whole or in part, without the prior written permission of John Snow Labs or the applicable trademark holder. You may not use any metatags or any other “hidden text” utilizing “John Snow Labs” or any other name, trademark or product, business or service name of John Snow Labs without our prior written permission. In addition, the look and feel of our Products, including all page headers, custom graphics, button icons and scripts, is the service mark, trademark and/or trade dress of John Snow Labs and may not be copied, imitated or used, in whole or in part, without our prior written permission. All other trademarks, pending trademarks, registered trademarks, product names and company names or logos mentioned in our Products are the property of John Snow Labs Inc. and/or their respective owners. Reference to any products, services, processes or other information, by trade name, trademark, manufacturer, supplier, or otherwise does not constitute or imply endorsement, sponsorship, or recommendation thereof by us.

Disclaimer of Warranties

YOUR USE OF THE PRODUCTS IS AT YOUR SOLE RISK. THE PRODUCTS AND CONTENT EACH ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. WE AND OUR SUPPLIERS AND LICENSORS EXPRESSLY DISCLAIM ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT. WE DO NOT GUARANTEE THE ACCURACY, COMPLETENESS, OR USEFULNESS OF THE PRODUCTS OR ANY CONTENT, AND YOU RELY ON THE PRODUCTS AND CONTENT AT YOUR OWN RISK. ANY MATERIAL THAT YOU ACCESS OR OBTAIN THROUGH OUR PRODUCTS IS DONE AT YOUR OWN DISCRETION AND RISK AND YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY MATERIAL THROUGH OUR PRODUCTS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM US OR THROUGH OR FROM OUR PRODUCTS WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THIS EULA. SOME STATES MAY PROHIBIT A DISCLAIMER OF WARRANTIES AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM STATE TO STATE.

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WE AND OUR SUPPLIERS AND LICENSORS WILL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF THESE DAMAGES), RESULTING FROM YOUR USE OF OUR PRODUCTS AND CONTENT. UNDER NO CIRCUMSTANCES WILL THE TOTAL LIABILITY OF US AND OUR SUPPLIERS AND LICENSORS OF ALL KINDS ARISING OUT OF OR RELATED TO YOUR USE OF THE PRODUCTS AND CONTENT (INCLUDING BUT NOT LIMITED TO WARRANTY CLAIMS), REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, OR OTHERWISE, EXCEED THE AMOUNTS, IF ANY, THAT YOU HAVE PAID FOR YOUR USE OF THE PRODUCTS AND CONTENT. BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

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To the full extent permitted by applicable law, you shall defend, indemnify and hold harmless John Snow Labs, its affiliates and its licensors, and each of their respective employees, officers, directors, and representatives from and against any claims, damages, losses, liabilities, costs, and expenses (including reasonable attorney’s fees) arising out of or relating to any third party claim concerning: (a) your use of the Products; (b) breach of this EULA or violation of applicable law by you; (c) any content or the combination of such content with other software, content or processes, including any claim involving alleged infringement or misappropriation of third-party rights by such content or combination; or (d) breach of any obligation or duty you owe to a third party.

Legal Notices

Enforcement of this EULA will be governed by the laws of the State of Delaware, excluding its conflict and choice of law principles. The exclusive jurisdiction and venue for any claims arising out of or related to this EULA or your use of the Products will lie in the state and federal courts located in Sussex County, within the State of Delaware, and you irrevocably agree to submit to the jurisdiction of such courts. Our failure to enforce any right or provision in this EULA will not constitute a waiver of such right or provision unless acknowledged and agreed by us in writing. In the event that a court of competent jurisdiction finds any provision of this EULA to be illegal, invalid, or unenforceable, the remaining provisions will remain in full force and effect.

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We may use your contact information to notify you if we have any legitimate interest or if we need to notify you on any important information related to your use of Products. We will not send you newsletters unless you expressly consented to such notifications.

Contacting Us

If you have any questions or concerns about our Products or this EULA, you may contact us by email at support@JohnSnowLabs.com.

Description

The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.

The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.

About this Dataset

Data Info

Date Created

2002

Last Modified

2022-09-21

Version

2022-09-21

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2022-09-21

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting

Other Titles

MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network

Data Fields

Name Description Type Constraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestring-
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-

Data Preview

Device BrandDevice ManufacturerDevice TypeDevice ProblemDate ReportEvent Description
BIOFLO VORTEX PORTANGIODYNAMICS INCPORT & CATHETER IMPLANTED SUBCUTANEOUS INTRAVASCULARPotential for patient harm2022-09-21Provider inserting an Angio Dynamic SmartPort Low Profile Port with Vortex Technology. During insertion - provider reported the wire became stuck inside the introducer.
Reciprocating Blade Heavy Duty Long Offset (77.6 x 0.77 x 11.2mm)STRYKER CORPORATIONBLADE SAW GENERAL & PLASTIC SURGERY SURGICALPotential for patient harm2022-09-20END OF STRYKER SAW BLADE 0277-096-325 (LOT:22031017 - EXP: 02/01/2027) BROKE INSIDE SYSTEM 8. NO PIECE OF SAW BROKE OFF INTO PATIENT. BLADE WAS REMOVED AND BROKEN PIECE STUCK INSIDE SYSTEM 8 HANDPIECE. CHARGE RN NOTIFIED - MANAGER NOTIFIED. NEW SYSTEM 8 AND NEW SAW BLADE OPENED AND USED WITHOUT FURTHER ISSUE. NO X-RAY VISUALIZATION REQUIRED PER Manager.
Perceval Sutureless Aortic Heart ValveLivanova Canada Corpheart-valve non-allograft tissueDeath2022-09-20Patient (pt) admitted with NSTEMI (Non-ST-elevation myocardial infarction) - aortic stenosis. Was taken to OR (operating room) by doctor. There were issues in OR with the aortic valve: requiring opening aorta multiple times and ultimately replacing valve twice. Pt had long pump time and required multiple blood products. Impella was placed and chest left open. Initial valve used was a sutureless valve that we have not used here. However - surgeon expressed that he was comfortable with valve. It was never determined why valve was nonfunctioning. Case should be reviewed. PI (patient identifier) Note: Person that entered SIR entered under incorrect visit.
Bard Nasogastric Sump TubeTUBE NASOGASTRICNot applicable;Potential for patient harm2022-09-20Hole found in Nasogastric Tube (NGT) shortly after placement. Hole located in the tubing were the blue tubing attaches to the clear plastic. RN discovered gastric contents leaking from tubing.
CoblationSMITH AND NEPHEW INC.ELECTROSURGICAL CUTTING COAGULATION ACCESSORIESNot known;Potential for patient harm2022-09-20Device plugged into coblater and will not work. Device unplugged - coblater turned off and then on again. Device still would not work. New device opened and plugged in and worked.
Spectrum IQBAXTER INTERNATIONAL INC.Pump InfusionSerious injury2022-09-20Baxter pump failed to alarm for an upstream occlusion for a kinked IV tubing. This patient is on a pressor - and this is the medication that is a part of this situation. The patient's BP started to drop suddenly - MD notified immediately - this RN having to titrate pressor up - however this entire time the IV tubing had a small barely noticeable kink that the IV pump probably should have alarmed for an upstream occlusion. Per clinical engineering: Pump was programmed for norepinephrine on [redacted date] at 17:07 in the logs (1:07pm) and there were a couple upstream occlusions over the next few days without the tubing being reloaded - which could have caused the sensor to be reset. The pump passed all the usual verification tests.
Concerto Detachable Coil System NylonMICRO THERAPEUTICS INC. DBA EV3Device Vascular for Promoting EmbolizationPotential for patient harm2022-09-20Doctor was attempting to deploy an embolization coil during a Hepatic Artery Radioembolization Planning exam. As the Coil was being advanced through the microcatheter - there was significant resistance. The coil was re-sheathed and the microcatheter was exchanged for a new microcatheter. Doctor then attempted to advance the coil - again meeting with resistance. The coil could not be advanced through the microcatheter and into the patient. The coil was removed/re-sheathed and sent to manufacturer as defective.
Resolution 360 clipBOSTON SCIENTIFIC CORPORATIONHemostatic metal clip for the GI tractPotential for patient harm2022-09-201. The Resolution 360 clip package labeled with a 1 in the top right corner deployed prematurely when device was opened. 2. The Resolution 360 clip package labeled with a 2 in the top right corner also deployed prematurely - but when device was closed.
Medline glovesMedline Industries Inc.Non-Powdered Patient Examination GloveNot applicable2022-09-19Gloves in clinic - many are glued together - and some have holes in them. Unfortunately - they were not in the original box - so we don't know exactly what box they came out of/size/etc.
Neonatal flow sensor insertDraegerwerk AG & Co. KGaATransducer Gas FlowNot applicable2022-09-19When the neonatal flow sensor was removed from the sterile processing package and placed in line with vent for testing - the neonatal flow sensor would not work. The knobs on the insert were bent in slightly and the flow sensor repeatedly failed calibration. It was unseated and placed in the housing several times - failing calibration every time. It is felt that the processing is causing the plastic to harden and the knobs to bend or break more easily when being removed or placed in the flowsensor. This directly affects the chip inside the flow sensor. This has happened 9 times in 15 processings so a failure rate greater than 50%.