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

MAUDE Adverse Event Report: DAVOL, C.R. BARD BARD MESH PERFIX PLUG, SIZE MEDIUM

  • 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
 

DAVOL, C.R. BARD BARD MESH PERFIX PLUG, SIZE MEDIUM Back to Search Results
Lot Number 43KMD059 ??
Event Date 12/22/2010
Event Type  Injury  
Event Description

Had a bard mesh perfix plug implanted to repair a right inguinal hernia in 2003. Experienced occasional excruciating pain and swelling after the recommended healing time passed, but was told by surgeon that healing can take a long time after surgery. As time went on, the pain became more and more frequent until it was so intolerable i knew something was very wrong. I was seen by another surgeon on (b)(6) 2010 and was schedule for corrective surgery the following day. I was told that the original mesh plug became detached from the muscle on one end and had folded up causing the intestine to poke through the opening and eventually get stuck. This resulted in the need for immediate corrective surgery to prevent bowel strangulation. The problem, i may be faced with now post surgery is possible permanent pain/discomfort/numbness from pubic area to thigh due to nerve damage. I've read reports from many other pts who experienced identical problems with this mesh plug; therefore, it is my hope that this plug will soon be added to the recall list to prevent future pts from having to experience these problems after hernia surgery.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD
Type of DeviceMESH PERFIX PLUG, SIZE MEDIUM
Manufacturer (Section D)
DAVOL, C.R. BARD
cranston RI
MDR Report Key1976659
Report NumberMW5019192
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number43KMD059 ??
OTHER Device ID NumberREF 0112760
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/27/2011 Patient Sequence Number: 1
-
-