• 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. BARD FLAT MESH 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. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112720
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Disability (2371)
Event Date 04/18/2006
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. Regarding infection, the warning section of the ifu states "if one develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " review of the device history records found lot was manufactured to specification. No anomalies identified. 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 a large epigastric hernia. As reported, a bard/davol marlex, (b)(4), lot number 43kpd179 was implanted to repair the hernia defect. It is alleged that on (b)(6) 2006, the patient underwent an additional surgery to remove infected hernia 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 marlex.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD FLAT MESH
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 Key7155073
MDR Text Key96059796
Report Number1213643-2017-01143
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPREAMENDMENT
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 EXPIRATION Date11/28/2010
Device Catalogue Number0112720
Device LOT Number43KPD179
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received12/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2005
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
-
-