BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3112826 · Received May 14, 2013

    Report

    Report Number
    1531186-2013-02068
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ANI [ A&I ] GROUP TAIWAN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGES THE PIVOT LINK BROKE AND IS NOT A REPLACEABLE PAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212250 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR ANI [ A&I ] GROUP TAIWAN IN86AHANFRFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other