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

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX SURGICAL MESH

  • 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 INC., SUB. C.R. BARD, INC. MESH - COMPOSIX SURGICAL MESH Back to Search Results
Catalog Number UNKAA018
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Disability (2371)
Event Date 01/23/2007
Event Type  Injury  
Manufacturer Narrative

To date, limited information has been provided. Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication. If additional information is obtained, a supplemental mdr will be submitted. Not returned.

 
Event Description

It is alleged by the patients attorney that on (b)(6) 2006, the patient underwent surgery for repair of an incarcerated ventral hernia. It is alleged that on (b)(6) 2007, the patient underwent an additional surgery to repair recurrent incisional hernia with removal of old mesh. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH - COMPOSIX
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
jessica messier
100 crossings blvd.
warwick, RI 02886
4018258720
MDR Report Key7155075
MDR Text Key96059531
Report Number1213643-2017-01144
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK971745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/29/2017 Patient Sequence Number: 1
-
-