BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOSUTURE

    MDR report key: 853170 · Received May 14, 2007

    Report

    Report Number
    MW1042870
    Event Type
    Other
    Date Received
    May 14, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 7, 2007
    Manufacturer
    AUTOSUTURE
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VALVE AT OPENING LOOSE AND FELL OFF INSIDE PATIENT. GOT ANOTHER TROCAR AND SAME THING HAPPENED. A NEW TROCAR FROM A DIFFERENT LOT # PLACED. GREY VALVE RETRIEVED FROM PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE BLUNT TIP TROCAR AND SYRINGE DRC AUTOSUTURE OMS-T10BT P6L641

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other