BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 746479 · Received September 29, 2005

    Report

    Report Number
    MW1036759
    Event Type
    Malfunction
    Date Received
    September 29, 2005
    Date of Event
    September 8, 2005
    Report Date
    September 16, 2005
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    FHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AUTOSUTURE SHAFT SNAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE OVAL PREP DISTENTION BALLOON & INFLATION BUL FHP UNITED STATES SURGICAL PDB S2 P4H607

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR