BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    34 INCH

    MDR report key: 1062384 · Received June 9, 2008

    Report

    Report Number
    1062384
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE DISPOSABLE 34 INCH ZIMMER TOURNIQUET WAS PLACED ON THE PATIENT'S RIGHT THIGH FOR A RIGHT TOTAL KNEE ARTHROPLASTY. AFTER REMOVING DRAPES AT END OF CASE, THE TOURNIQUET CUFF WAS NOTED TO HAVE "ROLLED OVER" ON ITSELF. THERE WAS A SKIN TEAR ON PATIENT'S THIGH, WHICH WAS APPROXIMATELY 1 INCH BY 1/4 INCH. THE ZIMMER REPRESENTATIVE WAS NOTIFIED, WHO MADE A REPORT FOR THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 34 INCH TOUNIQUET, DISPOSABLE KCY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS 60-7075-006 60605009

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR