BEUDAMED
    FDA Adverse Event Other Summary report: N

    PACESAVER

    MDR report key: 237929 · Received August 26, 1999

    Report

    Report Number
    1919278-1999-00003
    Event Type
    Other
    Date Received
    August 26, 1999
    Date of Event
    July 20, 1999
    Report Date
    August 25, 1999
    Manufacturer
    BURKE, INC.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER DRIVING UP LONG INCLINE. UNIT STALLED AND ROLLED BACKWARDS. USER TURNED TO SIDE AND RELEASED THE THROTTLE CAUSING BRAKE TO ENGAGE, STOPPING UNIT. USER FELL OFF LANDING ON OBJECT CRACKING TWO RIBS. RIBS TAPED BY MEDICAL PROFESSIONAL. NO DEFECT IN MATERIALS OR WORKMANSHIP. INCIDENT CAUSED BY LACK OF MAINTENANCE TO MOTOR. UNIT DID NOT TIP OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACESAVER ELECTRIC SCOOTER INI BURKE, INC. PACESAVER ECLIPSE PREMIER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention