BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT ADAPT T 15MM BARIATRIC PORT

    MDR report key: 1060705 · Received May 30, 2008

    Report

    Report Number
    3003898360-2008-00037
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Report Date
    April 7, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. A DETAILED REVIEW WILL BE PERFORMED AND WILL BE FORWARDED TO YOU WHEN AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT REPORTED: THE VALVE WHICH IS DESIGNED TO CLOSE OFF THE TROCAR AND HOLD EXPANSION GAS, BROKE LOOSE DURING A HYSTERECTOMY AND LODGED IN THE PELVIC AREA OF THE PATIENT. VALVE WAS RETRIEVED WITHOUT ISSUE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT ADAPT T 15MM BARIATRIC PORT BARIATRIC PORT GCJ TELEFLEX MEDICAL 07001

    Patients

    Seq Age Sex Outcome Treatment
    1