BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INION THERMO DRAPE/INION INSTRUMENT

    MDR report key: 809802 · Received November 12, 2004

    Report

    Report Number
    9710629-2004-00008
    Event Type
    Malfunction
    Date Received
    November 12, 2004
    Date of Event
    November 4, 2004
    Report Date
    November 11, 2004
    Manufacturer
    INION LTD
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STERILE THERMO DRAPE WAS PLACED IN WATERBATH, WHICH IS USED TO HEAT BIODEGRADABLE STERILE IMPLANTS, FILLED WITH WATER AND THEN THE WATERBATH WAS TURNED ON. ABOUT 45 MINS LATER, AS THE DOCTOR WAS PREPARING TO TAKE IMPLANTS, A SIGNIFICANT DROP IN WATER LEVEL WAS NOTICED. DRAPE FOR THE WATER BATH WAS LEAKING INTO THE WATER BATH ITSELF. THIS BROKE THE STERILE FIELD. THEY USED METAL PLATES INSTEAD FOR THE PELVIC APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION THERMO DRAPE/INION INSTRUMENT STERILE PLASTIC DRAPE KKX INION LTD ACC9802T 0406064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other