BEUDAMED
    FDA Adverse Event Other Summary report: N

    IVRA (BIER BLOCK) SET UP

    MDR report key: 230254 · Received July 1, 1999

    Report

    Report Number
    MW1016680
    Event Type
    Other
    Date Received
    July 1, 1999
    Date of Event
    June 25, 1999
    Report Date
    June 28, 1999
    Manufacturer
    ZIMMER, INC.
    Product Code
    KCY
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DOING A BIER BLOCK IN THE OR TO THE RIGHT ARM. WHEN SWITCHING TO THE 2ND LEVEL OF TOURNIQUET, THE 2ND LEVEL FAILED. THE PT GOT A BOLUS OF XYLOCAINE 0.5% AND DESCRIBED A MAJOR HEADACHE. THE PT WAS MONITORED IN THE HOLDING ROOM FOR AT LEAST AN HR AFTER THE PROCEDRURE. VITAL SIGNS REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVRA (BIER BLOCK) SET UP 18 INCH TOURNIQUET (48 CM) KCY ZIMMER, INC. CE 2084 (1915) *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other