New Mobile App for Reporting Medical Device Problems to the FDA

By Cullan & Cullan on May 8, 2013 - Comments off

A new mobile application will let individuals voluntarily submit problems with medical devices directly to the U.S. Food and Drug Administration (FDA).  According to, the new application will enable caregivers, health care professionals, and patients to voluntarily report problems to the FDA.

The application is called “MedWatcher.”  App users will be able to point out visible problems such as corrosion or breakage of medical devices by uploading pictures of the devices.  The app makes reporting issues easier and faster than using traditional methods of reporting by phone call, mail, or use of an online reporting form.  FDA safety communications, recall information, and safety alerts can be automatically received just as news alerts can be received on iPads or iPhones.

Events that could be reported by using the new app include the following:

  • Instances in which the medical device failed to function as it should have
  • Medically serious events associated with use of a medical device
  • Device use errors due to directions, packaging, etc.
  • Potential contamination
  • Defective components

The app’s creators have taken steps to ensure confidentiality and a strong firewall has been built for incoming reports.  That way the information contained will not be susceptible to any unauthorized access.  The app itself does not store reports of problems once they are submitted to the FDA.  The personal privacy settings on the mobile device are not altered or interfered with in any way.

At the law firm of Cullan & Cullan, our attorneys want you to know that even though you may have put your trust in medical professionals who use medical devices, these products can be harmful to patients when they are defective.  Our Omaha defective medical product attorneys are also doctors who know how to help you recover the compensation you may deserve if you are harmed by a defective medical device.   Call (402) 397-7600 to discuss your situation in a free initial consultation.

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