Medical Product Safety Network

$199 / year

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).

Complexity

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.

Date Created

2002

Last Modified

2018-10-18

Version

2018-10-18-10-11-09-25-09-19-09-17-09-13-09-06-08-30-08-22-08-16-08-08-08-01-07-24-07-18-07-11-07-03-06-29-06-20-06-13

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2018-10-18

Spatial Coverage

United States

Source

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

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestringrequired : 1
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-
Device_BrandDevice_ManufacturerDevice_TypeDevice_ProblemDate_ReportEvent_Description
unknownunknownNot known2018-03-01Nothing
Heart Valve - Aortic2014-01-30Failed heart valve.
Ascent5mm TrocarNot known2011-03-09Trocar not working.
MedtronicLeadNot known2014-01-30The lead for the device broke.
IridexLaser ProbeNot known2010-09-16Device Failed to Fire.
HYSTEROSCOPY FLUIDNot known2014-09-15Hysteroscopy fluid deficit
NGageCook Medicalextractor stone basket2013-04-17The basket broke.
LOIAbbott Medical Opticsunit phacofragmentation2015-12-01Water leaked.
Natus Medical Inc.LampNot applicable2011-09-14The lamp would not work.
HospiraIntravascular TubingNot known2012-03-15Tubing would not flush.