BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4953227 · Received September 30, 2013

    Report

    Report Number
    9612393-2013-00193
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Report Date
    September 30, 2013
    Manufacturer
    TAIWAN AN I CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO WAY TO KNOW WHETHER THIS DEVICE WAS MANUFACTURED BY A AND I INDUSTRIES LTD SINCE THERE WAS NO MODEL NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: LEVER BARS ARE SNAPPING ON ENDS WHEN DEALER IS USING THEM TO INSTALL TIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494002 MECHANICAL (MANUAL) WHEELCHAIR WHEELCHAIR IOR TAIWAN AN I CO.,LTD. 13110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other