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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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 | 2024-06-13 |
Version | 2024-06-13 |
Update Frequency |
Daily |
Temporal Coverage |
2006-03-24 to 2024-06-13 |
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_Brand | The brand of medical device | string | - |
Device_Manufacturer | Device manufacturer name | string | - |
Device_Type | The type of medical device | string | - |
Device_Problem | Problem associated with the device | string | - |
Date_Report | The Date report | date | required : 1 |
Event_Description | The Event description | string | - |
Data Preview
Device Brand | Device Manufacturer | Device Type | Device Problem | Date Report | Event Description |
Merge Hemo | Merge Healthcare | COMPUTER DIAGNOSTIC PROGRAMMABLE | Potential for patient harm | 2024-08-27 | Merge had a spinning wheel on screen during a procedure. Registered nurse (RN) waited approximately 4 minutes and then rebooted to be able to continue documenting. Patient was a post-STEMI (ST-elevation myocardial infarction) with severe coronary disease. Rebooted Merge to continue ability to monitor and document in Merge. |
Merge Hemo | Merge Healthcare | COMPUTER DIAGNOSTIC PROGRAMMABLE | Potential for patient harm | 2024-08-27 | During procedure - device malfunction as multiple times - inaccurate heart rates were viewed. Troubleshooting during procedure; tried different leads and lead placement with no resolution. Used anesthesia monitor to complete case. |
HOT PACK SMALL 4.5X9IN | CARDINAL HEALTH 200 LLC | PACK HOT OR COLD DISPOSABLE | Potential for patient harm;Minor injury to the patient or health care provider | 2024-08-27 | staff member attempted to pop the heat pack to activate it; it burst open and contents came in contact with staff member's eyes |
Merge Hemo | Merge Healthcare | COMPUTER DIAGNOSTIC PROGRAMMABLE | Potential for patient harm | 2024-08-27 | Transcatheter Aortic Valve Replacement (TAVR) procedure scheduled for Cardiac Catheterization Laboratory (CCL): no heart rate (HR) noted. On Lead 3 then changed to AVL. Good wave form no HR. Blood pressure(BP) and oxygen (O2) were being monitored on anesthesia machine. Room had been re-booted in the morning prior to case start and leads tested - was able to get accurate HR changing leads multiple times abdominal finding HR on AVL lead. |
FastLoad CTA Dual Syringe Pack | Bracco Injeneering SA | Injector And Syringe Angiographic | Potential for patient harm | 2024-08-26 | Procedure: CT - During procedure - the contrast leaked from tubing or connection site of tubing/syringe. Did have to reload contrast to inject patient. No known harm to patient. ====================== Manufacturer response for Injector And Syringe - Angiographic - FastLoad CTA Dual Syringe Pack (per site reporter) ====================== Will obtain. |
FastLoad CTA Dual Syringe Pack | Bracco Injeneering S.A. | Injector And Syringe Angiographic | Potential for patient harm | 2024-08-23 | Procedure: CT - New Bracco- Fastload CTA dual syringe pack opened- Missing 1 syringe cap and tubing. Not used on patient. ====================== Manufacturer response for Injector And Syringe - Angiographic - FastLoad⢠CTA Dual Syringe Pack (per site reporter) ====================== Will obtain. |
FastLoad CTA Dual Syringe Pack | Bracco Injeneering S.A. | Injector And Syringe Angiographic | Potential for patient harm | 2024-08-23 | Procedure: CT - New Bracco- Fastload CTA dual syringe pack opened- Missing straw and tubing. Not used on patient. ====================== Manufacturer response for Injector And Syringe - Angiographic - FastLoad CTA Dual Syringe Pack (per site reporter) ====================== Will obtain. |
FastLoad CTA Dual Syringe Pack | Bracco Injeneering S.A. | Injector And Syringe Angiographic | Potential for patient harm | 2024-08-23 | Procedure: CT - New Bracco- Fastload CTA dual syringe pack opened- Missing the tubing. Not used on patient. ====================== Manufacturer response for Injector And Syringe - Angiographic - FastLoad CTA Dual Syringe Pack (per site reporter) ====================== Will obtain. |
NeoMagic | NEO MEDICAL INC. | Introducer Syringe Needle | Potential for patient harm | 2024-08-21 | While placing a peripherally inserted central catheter (PICC) line - I attempted to break the modified Seldinger introducer. Instead of splitting down the middle allowing me to remove the introducer - one blue wing broke off completely. Leaving the remainder of the plastic catheter around the line. Much effort was given to split the introducer. It took over 20 minutes and I was very concerned about dislodging the PICC or harming it in the process. Eventually it split and I was able to proceed with the line placement. This was on a micro premie with very limited veins. This was incredible stressful on a very delicate/fragile patient. ====================== Manufacturer response for Introducer - Syringe Needle - NeoMagic (per site reporter) ====================== Issues ongoing with this product - still no resolve on investigations. We have sent samples and await their conclusions. |
MAHURKAR Elite | Covidien LP | CATHETER HEMODIALYSIS NON-IMPLANTED | Serious injury | 2024-08-21 | The event involved an elderly female with a past medical history of thrombocytopenia - hypertension - and hyperlipidemia. The patient was admitted with altered mental status and acute kidney injury - later diagnosed with microangiopathic hemolytic anemia. On [redacted date] - an experienced intensive care unit (ICU) provider inserted a left internal jugular double lumen central line catheter for plasmapheresis treatment. The provider followed the standard ICU practice without complications. That night - despite the lines flushing well - there was poor blood return and sluggish flow noted during plasmapheresis treatment. Consequently - the ICU team decided to insert a second double lumen central line catheter and remove the first central line catheter. The removal of the left internal jugular catheter was performed at the ICU bedside per the standard of practice. The ICU provider that removed the catheter inspected and noted that the catheter tip was intact. A chest computerized tomography (CT) on [redacted date] revealed a foreign body in the right lower pulmonary artery. On [redacted date] had the foreign body removed without complications. The foreign body was determined to be a retained catheter tip. Manufacturer response for CATHETER - HEMODIALYSIS - NON-IMPLANTED - MAHURKAR Elite (per site reporter) Covidien rep notified by our Materials Management team. |