BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX

    MDR report key: 2483342 · Received December 6, 2011

    Report

    Report Number
    MW5024545
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    October 17, 2011
    Report Date
    December 6, 2011
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFECTED HERNIA REPAIR MESH. HERNIA REPAIR MESH, IMPLANTED (B)(6) 2010, WAS INFECTED WITH SEVERAL STRAINS OF (B)(6), REQUIRING SURGICAL REMOVAL. IMPLANTED DEVICE: KUGEL MESH, BARD COMPOSIX, LARGE W/EPTFE, 14 CM X 18 CM. PRODUCT CODE: 0010202, LOT NUMBER: HUTL0244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL MESH, LARGE OVAL 14CM X 18CM FTL DAVOL, A BARD COMPANY 0010202 HUTL0244

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Congenital Anomaly| H| L| O| R| S