BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3100803 · Received May 8, 2013

    Report

    Report Number
    1531186-2013-01958
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN WHEEL SPOKE ON A V18RLR MANUAL WHEELCHAIR. THIS COMPROMISES THE WEIGHT BEARING STATUS OF THE CHAIR CREATING THE POTENTIAL FOR A FALLING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201029 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT V18RLR

    Patients

    Seq Age Sex Outcome Treatment
    1 16 Other