BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADI

    MDR report key: 499027 · Received November 20, 2003

    Report

    Report Number
    MW1030370
    Event Type
    Injury
    Date Received
    November 20, 2003
    Date of Event
    November 4, 2003
    Report Date
    November 11, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/25/04: LOT NUMBER: D1923 INDICATED IN REPORT AND FOUND ON OUTER BOX. DEVICE RETURNED TO POUCH WITH LOT NUMBER D1918. THE EVENT IS DESCRIBED AS FOLLOWS IN BOTH REPORTS: "PHYSICIAN ATTEMPTED TO PLACE FEMSTOP. INFLATED ON PT AND WOULD NOT HOLD AIR IN FEMOSTOP BALLOON." NO PT PROBLEMS WERE REPORTED IN ANY OF THE REPORTS. THE PNEUMATIC PRESSURE DOME WAS SUBMERGED IN WATER AND INFLATED BY A PUMP. A LEAKAGE WAS FOUND WHERE DOME IS GLUED TO THE ARCH. THE COMPLAINT WAS CONFIRMED. IT WAS NOT POSSIBLE TO KEEP THE PRESSURE DOME INFLATED. THE EVENT CAN BE ATTRIBUTED TO FAILURE OF THE DEVICE. A COMPLAINT REPORT WAS SENT FROM THE CUSTOMER DIRECTLY TO RADI MEDCIAL SYSTEMS, INC DECEMBER 12, 2003. THE ACTUAL DEVICE WAS FORWARDED TO RADI MEDICAL SYSTEMS AB, FOR EVALUATION JAN 19, 2004. THE MODEL, 11162, INVOLVED IN THE REPORTED EVENT, IS NO LONGER MANUFACTURED. THE DOME OF THE PRESENTLY PRODUCED MODEL OF FEMOSTOP FEMORAL COMPRESSION SYSTEM, CATALOGUE NUMBER 11163, IS GLUED TO THE ARCH BY A DIFFERENT PROCESS.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO PLACE FEMOSTOP. INFLATED ON PT AND WOULD NOT HOLD AIR IN FEMOSTOP BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADI FEMORAL COMPRESSION SYSTEM MGB RADI MEDICAL SYSTEMS, INC. REF #11162 D1923

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention