• 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. SEPRAMESH IP

  • 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. SEPRAMESH IP Back to Search Results
Catalog Number 00000000
Event Type  Injury  
Event Description

Surgeon reported to sales rep that he has had 3 similar cases as follows: pt underwent sepramesh ip mesh implant. Subsequently, the pt developed an infection. The device was explanted due to infection and the case involved staph aureus.

 
Manufacturer Narrative

We have contacted the initial reporter to request additional info and to request return of the device for evaluation. This mdr includes all pt, event and device info davol has received to date. It has been reported that the surgeon is performing testing and analysis on the explanted material, therefore, no sample has been returned to davol for evaluation. A dhr review has not been conducted, since no specific product code or lot number have been provided. Currently, it is unk whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. See mdr 1213643-2010-00094 and 1213643-2010-00096 for info related to the other two reported occurrences of the same issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEPRAMESH IP
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
warwick RI
Manufacturer (Section G)
GENZYME CORPORATION
80 new york ave
framingham MA 01701 880
Manufacturer Contact
lori laplume
100 crossing blvd.
warwick , RI 02886
8005566756
MDR Report Key1629508
Report Number1213643-2010-00095
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/05/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number00000000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received02/05/2010
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: 03/05/2010 Patient Sequence Number: 1
-
-