BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON INC.

    MDR report key: 1157931 · Received September 10, 2008

    Report

    Report Number
    MW5008279
    Event Type
    Injury
    Date Received
    September 10, 2008
    Date of Event
    June 27, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADMISSION S/P HERNIA REPAIR WITH FISTULA. TO OR FOR REPAIR. RETURNED OR FOR REPAIR EVISCERATION. MESH PLACED PRIOR TO EVENT DATE, IN THE EVENT DATE MESH TORE. RETURN TO OR, MESH REPLACED IN THE FOLLOWING MONTH - 2ND EVENT, OR REPLACED MESH AGAIN. PMH: HTN, OBESITY BMI 33.4, SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON INC. VICRYL BRIDGE MESH FTL ETHICON INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization