Medical Devices

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair SUI and POP please include the following information in your reports, if available:

  • Manufacturer's name
  • Product name (brand name)
  • Catalog number
  • Lot number
  • Size
  • Date of implant
  • Date of explant (if mesh was removed)
  • Details of the adverse event and medical and/or surgical interventions (if required)
  • Reason for mesh implantation: (e.g., SUI; POP)
  • Type of procedure (e.g., Sling procedure: retropubic, transobturator, or mini-sling procedure for SUI; anterior repair, vaginal vault suspension, or posterior repair, for POP repair)
  • Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
  • Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at industry.devices@fda.hhs.gov, 800-638-2041 or 301-796-7100.
 

Page Last Updated: 03/27/2013
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