BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS WAVE III

    MDR report key: 1271453 · Received December 12, 2008

    Report

    Report Number
    1271453
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    November 12, 2008
    Report Date
    December 12, 2008
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE (9 MINUTES INTO THE TOURNIQUET TIME), THE THIGH WAS NOTED TO BE EXTREMEMLY HARD AND THE PHYSICIAN NOTED SWELLING IN THE LEFT THIGH. THE TOURNIQUET WAS DEFLATED IMMEDIATELY. THE SWELLING DID SUBSIDE AFTER WRAPPING THE THIGH AS FLUID WAS RELEASED. THE MANUFACTURER'S REPRESENTATIVE DID EVALUATE THE DEVICE AND NOTED A LEVER THAT WAS FROZEN AND WOULD NOT MOVE BUT THIS WAS NOT FELT TO HAVE EFFECTED THE PROPER FUNCTIONING OF THE PUMP. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION WITH NO SIGNS OF COMPARTMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS WAVE III PUMP, ARTHROSCOPY HRX ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NO OTHER THERAPIES| NO OTHER THERAPIES