• 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. KUGEL PATCH

  • 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. KUGEL PATCH Back to Search Results
Catalog Number 00000000
Event Type  Injury  
Event Description

Pt reported: in 2005 - pt underwent hernia repair with kugel mesh implant. In 2006 - pt began having mild infections and some pain at the site. In 2007 - pt began having increasingly more infections, swelling and more pain at the site. In 2009 - pain became unbearable, pt reports his bowels are protruding at the patch (hernia recurrence), constant infection, persistent redness and tenderness.

 
Manufacturer Narrative

We have contacted the initial rptr to request add'l info and to request return of the device for eval. This mdr includes all pt, event and device info davol has received to date. Currently, it is unknown 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKUGEL PATCH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
warwick RI
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
lori laplume
100 crossing blvd.
warwick , RI 02886
8005566756
MDR Report Key1644487
Report Number1213643-2010-00120
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/23/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2010
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 Home
Date Manufacturer Received02/23/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/25/2010 Patient Sequence Number: 1
-
-