BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2090269 · Received May 12, 2011

    Report

    Report Number
    2090269
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    SURGICAL STAFF OPENED A NEW REPROCESSED TOURNIQUET TO PLACE ON PATIENT. ONCE UNROLLED, IT WAS OBVIOUS THE RIGID PLASTIC CONTAINED WITHIN THE CUFF WAS BROKEN INTO TWO PIECES. THE TOURNIQUET DID NOT REACH THE PATIENT, BUT WAS SEQUESTERED FOR REPORTING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TOURNIQUET SINGLE HOSE SINGLE BLADDER (PLC SNAP CONNECTOR) 3 KCY ZIMMER ORTHOPAEDIC SURGICAL 60-7075-106 1533981

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR