BEUDAMED
    FDA Adverse Event Summary report: N

    KUGEL HERNIA PATCH

    MDR report key: 1241947 · Received November 14, 2008

    Report

    Report Number
    1241947
    Date Received
    November 14, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 14, 2008
    Manufacturer
    DAVOL INC. SUBSIDIARY OF CR BARD INC
    Product Code
    FTL
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO THE OR FOR EXPLANTATION OF A MRSA INFECTED KUGEL HERNIA PATCH, WHICH HAD BEEN IMPLANTED FEBRUARY 2003. THE PROCEDURE PERFORMED WAS: EXCISION OF ABDOMINAL WALL MESH AND REPAIR OF RESULTANT EPIGASTRIC DEFECT WITH 20 X 10 CM PERMACOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL HERNIA PATCH MESH, SURGICAL, HERNIA FTL DAVOL INC. SUBSIDIARY OF CR BARD INC * 43KMD157

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR CARDIAC DRUGS| CARDIAC DRUGS| LONG-TERM ANTIBIOTICS| LONG-TERM ANTIBIOTICS