• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIA SYNTHETIC MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HERNIA SYNTHETIC MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Degraded (1153); Folded (2630)
Patient Problems Adhesion(s) (1695); Pain (1994); Discomfort (2330); No Code Available (3191); Constipation (3274)
Event Date 08/25/2015
Event Type  Injury  
Event Description

Synthetic mesh implant in 2005, constant pain and discomfort, lived with it, 2012 digestive issues added, multiple er visits, constipation, intestines blocked, 2015 no bowel movement, rushed to er toxins backing up, ng tube attempted, rushed to "exploratory" surgery, incision from belly button down, mesh immediately visible and degradation seen, portions folded over looped in small intestine, partial mesh and dead small intestine, unable to remove remaining damaged mesh due to adhesions. In 2017 complications are back. Getting run around along with battery of test to exclude any other possible issue. Not wanting to acknowledge remaining mesh seems to be causing blockage again.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHERNIA SYNTHETIC MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key7553390
MDR Text Key109762958
Report NumberMW5077535
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 05/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/29/2018 Patient Sequence Number: 1
-
-