Postmarket Information - Device Surveillance and Reporting Processes
Use Error Reporting
A use error refers to a situation in which the outcome of device use was different than intended, but not due to malfunction of the device. The error may have been due to a poorly designed device, or it may have been used in a situation that promoted incorrect usage. Other users may make the same use error with similar or worse consequences. You can help us identify these errors by reporting the actual events and near misses that occur at your facility.
When reporting an adverse event, reporters often leave out details of the event that can be useful in identifying the factors or conditions that led to the event. Reports are more helpful if you describe the scenario as concretely as you can.
Good example of problem description:
“Nurse was changing the concentration of a prescribed medication being infused through a pump. In programming a bolus before the concentration change, she misunderstood the default settings and accepted the bolus concentration as the final dose. As a result, the patient received a three-fold overdose.”
In addition to a full description, other important and helpful information to include in the report is:
- Device type, manufacturer, brand name, and lot number if applicable
- The exact location of the event
- Was the patient or device operator harmed?
- Was the problem with the device a defect, malfunction, break, etc.?
- Was someone directly “operating the device at the time of the event? If so, who?
- Were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event?
Postmarket Reporting of Adverse Events, Use Errors and Product Problems
- Medical Device Reporting (MDR)
- Applies to manufacturers, importers, and user facilities
- Requires reporting of all significant medical device adverse events
- Applies to consumers and healthcare professionals
- Accepts voluntary reports of significant adverse events or problems with medical products
- Mandatory Reporting of Adverse Events (Form 3500A)
- eMDR - Electronic Medical Device Reporting
- Voluntary Reporting of Adverse Events, Use Errors and Product Problems (Form 3500) - In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of adverse events and product problems. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.
- MedSun: Medical Product Safety Network
FDA has also developed a pilot program to make reporting and follow-up on adverse events easier through a program called MedSun. MedSun is a partnership between FDA and over 300 hospitals and nursing homes. The MedSun system is used to identify problems and work with the manufacturer to produce a safer product.
- Reporting Unlawful Sales of Medical Products on the Internet
Postmarket Data Sources
- Medical Device Recalls
- Medical Device Safety: Safety Communications
- MedWatch Safety Alerts for Human Medical Products
- Medical Product Safety Educational Resources
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff (PDF - 528KB)
- YouTube videos: FDA Site