BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX KUGEL HERNIA PATCH 10"X 13"

    MDR report key: 755909 · Received August 18, 2006

    Report

    Report Number
    MW1040113
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    August 16, 2006
    Report Date
    August 18, 2006
    Manufacturer
    DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD AN INCISIONAL HERNIA REPAIR WITH MESH AND LEFT INGUINAL HERNIA WITH MESH. IMPLANTED WAS A VOLUNTARY RECALL BY BARD COMPOSIX KUGEL HERNIA PATCH 25.4CM X 33.0CM OVAL REF #0010207 LOT # 43END339. PT RETURNED TO THE OR A MO LATER WITH ABDOMINAL ABSCESS, POSSIBLE COLON FISTULA AND UNDERWENT A COLECTOMY, APPENDECTOMY, REMOVAL OF MESH, LYSIS OF ADHESIONS, REPAIR OF ABDOMINAL WALL DEFECT WITH PERMACOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL HERNIA PATCH 10"X 13" * FTL DAVOL 0010207 43END339

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| S