BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE SCOOTER

    MDR report key: 628219 · Received August 16, 2005

    Report

    Report Number
    1525712-2005-00059
    Event Type
    Malfunction
    Date Received
    August 16, 2005
    Date of Event
    July 20, 2005
    Report Date
    August 15, 2005
    Manufacturer
    TUNG KENG ENTERPRISE CO. LTD
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE FORWARD/REVERSE PIECE BROKE ON THE SCOOTER, CAUSING CONSUMER TO RUN INTO A WALL. NO SERIOUS INJURY ALLEGED. UNKNOWN MINOR HAND INJURY REPORTED. DEVICE MANUFACTURED BY TUNG KENG ENTERPRISE CO. LTD (3002667030). THROTTLE SPRING, LOCATED IN THE HAND THROTTLE ASSEMBLY, FRACTURED. FRACTURE OF SPRING CAN RESULT IN THE SCOOTER NOT STOPPING WHEN THE USER RELEASES THE THROTTLE. SPRING FUNCTION IS FOR THE THROTTLE HANDLE TO SPRING TO THE NEUTRAL / STOP POSITION WHEN RELEASED. UNDER FAILURE THIS FEATURE IS LOST. THE DISTRIBUTOR OF THIS PRODUCT HAS PLACED ALL UNITS THAT REMAIN WITHIN CONTROL ON HOLD. TO DATE NO INJURIES HAVE BEEN REPORTED TO DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SCOOTER 890.3800 INI TUNG KENG ENTERPRISE CO. LTD HMV 220 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR