Home   |   Donate   |   Industry   |   Print Page   |   Your Cart   |   Sign In   |   Join Now
Keyword Search
Help Yourself and Others: Report Problems
Share |

               If you have a shipment of leaky feeding bags, it may be clear to you that you need to call the supplier who delivered them to get them replaced. Did you know it can be helpful to report these and other problems you have with medical devices to the manufacturers and the FDA, as well? Your reports allow manufacturers and regulators to know if a problem is isolated or widespread, and to track patterns.

 

               The FDA encourages patients and health care professionals to report product problems and medical device adverse events to them through their MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Use the MedWatch program to report serious drug side effects, product use/medication errors, product quality problems, and therapeutic failures for medical devices (tubes, pumps, etc.), tube feeding formula, supplements, and medications, as well as biologics, foods, and cosmetics.

 

               To report a problem to the FDA’s MedWatch program, complete the online form at www.accessdata.fda.gov/scripts/medwatch/index.cfm or call (800) 332-1088 to request a reporting form, then complete and return it by mail to the address on the form or by fax to (800) FDA-0178.

 

               For more information on reporting problems with medical devices to the FDA, visit www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

 

               You can also look in the MAUDE database, maintained by the FDA, to see if problems have been reported with a medical device. Go to www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.


LifelineLetter, September/October 2019

 

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
Membership Management Software Powered by YourMembership  ::  Legal