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Got a complaint about a medical device or drug? There's an app for that

Consumer Reports News: April 29, 2013 01:08 PM

If you've experienced problems with a medical device (or even with medications and vaccines) the Food and Drug Administration wants you to know that now there's a free app to help you report it to the FDA.

The agency relies on voluntary public reporting as an important way to help its investigators identify and respond to signals of safety problems possibly associated with medical products, the FDA said. With the MedWatcher app for smart phones and tablets, you can even upload photographs of medical devices, which can help identify visible problems with the device, such as breakage or corrosion.

The app also enables you to automatically receive the FDA's MedWatch safety alerts, announcements of recalls, and other information.

Read our recent investigation of medical implants including our advice on how to guard against the risks posed by dangerous devices. And tell us if you've experienced a problem with an implant or a medical device by going to

The FDA said last week that patients, caregivers and other healthcare professionals can use the MedWatcher app to report the following types of problems, even when they are not certain that their medical implant or device caused the problem (FDA investigators will sort it out):
• Fatalities, hospitalizations, and other medically significant events.
• Therapeutic failures in which the device did not work as it should.
• Errors with devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.
• Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

Bottom line: The FDA touts the app as easier and faster than traditional reporting methods such as by snail mail, phone or online.

MedWatcher Mobile App [FDA web page]

Doug Podolsky

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