BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1386938 · Received May 15, 2009

    Report

    Report Number
    1213643-2009-00230
    Event Type
    Injury
    Date Received
    May 15, 2009
    Report Date
    April 22, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT DOES NOT INDICATE ANY SPECIFIC PRODUCT PROBLEM. IN ADDITION, 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. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADDITIONAL INFORMATION BECOMES AVAILABLE. INFORMATION RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED IN 2004 WILL BE REPORTED IN ACCORDANCE WITH RAE. SEE MDR 121364-2009-00229 FOR INFORMATION RELATED TO THE PREFIX PLUG MESH IMPLANTED IN 2006.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2004 - THE PT UNDERWENT A HERNIA REPAIR PROCEDURE WITH PLACEMENT OF A COMPOSIX KUGEL MESH PATCH. IN 2006 - THE PT PRESENTED TO HER PHYSICIAN IN DISTRESS WITH ABDOMINAL PAIN AND FEVERS. THE PT WAS ADMITTED TO SURGERY. THE PHYSICIAN NOTED A DEFECT FROM THE PREVIOUSLY PLACED MESH PATCH AND HAD TO REPAIR AND FREE SURROUNDING TISSUE. BARD PERFIX PLUG WAS INSERTED. IN EARLY 2007 - THE PT HAD A KUGEL MESH PATCH IMPLANTED. THUS FAR EACH OF THE THREE PATCHES IMPLANTED FAILED AND CAUSED ADHESIONS AND PERFORATIONS. THE PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening