BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP 34X4,1BLA,1PRT QUICK

    MDR report key: 2803207 · Received March 27, 2009

    Report

    Report Number
    2648666-2009-00220
    Event Type
    Malfunction
    Date Received
    March 27, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    KCY
    PMA / PMN Number
    K952038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE INCORRECT ADDRESS. THE DEVICE HAS BEEN SHIPPED TO THE CORRECT ADDRESS AND WILL BE INVESTIGATED UPON RECEIPT. THE DEVICE HAS NOT BEEN INVESTIGATED. WHEN THE INVESTIGATION IS COMPLETE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF HELD PRESSURE FOR THE BEGINNING OF THE PROCEDURE, BUT LOST PRESSURE ABOUT MID WAY THROUGH. THERE WAS BLEED THROUGH REPORTED, BUT THERE WERE NO ADVERSE CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP 34X4,1BLA,1PRT QUICK PNEUMATIC TOURNIQUET KCY STRYKER INSTRUMENTS PUERTO RICO 09020012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK