BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP 18X3, 1BLA, 2PRT QUICK

    MDR report key: 1033049 · Received April 22, 2008

    Report

    Report Number
    2648666-2008-00046
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL AND THEREFORE, CONDITION COULD NOT BE CONFIRMED. BATCH RECORDS WERE NOT REVIEWED SINCE THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF WAS BEING USED ON THE PT'S ARM, AND IT WAS SLOWLY LOSING PRESSURE OVER TIME. THE DR REPORTED THAT THERE WAS BLOOD IN THE WOUND SITE AND HE NOTICED THAT THE PT'S SKIN WAS COMING BACK TO BEING A PINK COLOR WHICH INDICATES THAT THE CUFF WAS NOT HOLDING THE PRESSURE. IT IS UNK HOW MUCH BLOOD WAS LOST; HOWEVER, THE PT DID NOT REQUIRE ANY ADDITIONAL BLOOD AND NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP 18X3, 1BLA, 2PRT QUICK PNEUMATIC TOURNIQUET HRX STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK