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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP Back to Search Results
Catalog Number 5959812
Event Date 01/16/2008
Event Type  Injury  
Event Description

Per information extracted via medical record review: on (b)(6) 2004- incision hernia repair with composix kugel mesh. On (b)(6) 2005- bulging on abdominal wall; no palpable sign of hernia, no discomfort. On (b)(6) 2005-recurrent incisional hernia. On (b)(6) 2006-recurrent hernia repair with composix kugel. Previous mesh was intact. Subsequent office visits, no infection, probable seroma around graft. On (b)(6) 2006-pain and discomfort. Area medially where mesh could be felt, may be calcified or been displaced. On (b)(6) 2006-office visit. Graft appeared to be bunched up. On (b)(6) 2007- removal of ((b)(6) 2006) composix kugel mesh & placement of proceed mesh. Patch easily palpable through anterior abdominal wall; caused pain at place that had apparently kinked. On (b)(6) 2007-office visit noted recurrent incisional hernia. On (b)(6) 2008- incisional hernia repair with sepramesh ip implant to reinforce composix kugel in lower midline. The sepramesh ip was tailored to size at the time of the implant and was sewn laterally to the previous composix kugel mesh already in place. On (b)(6) 2008- incision and drainage, irrigation, placement of jp drain over hernia patch, infected seroma around previously placed hernia patch. On (b)(6) 2008- removal of prosthetic mesh, wound irrigation, alloderm. Culture negative.

Manufacturer Narrative

We have contacted the initial reporter to request additional information and to request return of the device for evaluation. This mdr includes all patient, event and device information davol has received to date. The information provided indicates that the patient developed and was treated for an infection. The infection occurred shortly after the (b)(6) 2008 procedure. The warning section of the ifu states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. " see mdr 1213643-2010-00425 for information related to the composix kugel mesh implanted on (b)(6) 2006. See mdr 1213643-2010-00426 for information related to the composix kugel mesh implanted on (b)(6) 2004.

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Manufacturer (Section D)
warwick RI
Manufacturer (Section G)
80 new york ave
framingham MA 01701 880
Manufacturer Contact
paula lusignan
100 crossing blvd.
warwick , RI 02886
MDR Report Key1864667
Report Number1213643-2010-00428
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 06/21/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5959812
Device LOT Number07NPO055
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received06/21/2010
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

Date Received: 10/04/2010 Patient Sequence Number: 1