BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP 30X4, 1BLA, 1PRT QUICK

    MDR report key: 2042805 · Received March 30, 2011

    Report

    Report Number
    2648666-2011-00085
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    KCY
    PMA / PMN Number
    K924273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED BY THE MANUFACTURER BECAUSE, THE ACCOUNT DID NOT PLAN ON RETURNING THE PRODUCT AND HAS SINCE DISCARDED IT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE TOURNIQUET CUFF WOULD NOT HOLD PRESSURE DURING A SURGICAL PROCEDURE WHICH RESULTED IN BLEED THROUGH INTO THE SURGICAL SITE. THE CUFF WAS NOT REPLACED. ALTHOUGH, THERE WAS DELAY IN THE PROCEDURE, THE CUSTOMER WAS ABLE TO FINISH THE CASE. THERE WAS NO PATIENT/USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP 30X4, 1BLA, 1PRT QUICK KCY STRYKER INSTRUMENTS PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK