BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4953970 · Received September 30, 2013

    Report

    Report Number
    9612393-2013-00147
    Event Type
    Injury
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO WAY TO KNOW WHETHER THIS DEVICE WAS MANUFACTURED BY (B)(4) SINCE THERE WAS NO MODEL NUMBER PROVIDED AND THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: (B)(6) 2012, RBS - THE DEALER REPORTED THAT THE UNK MODEL AND SERIAL NUMBERS MECHANICAL WHEELCHAIR WHEEL LOCKS WERE NOT HOLDING. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493949 MECHANICAL (MANUAL) WHEELCHAIR WHEELCHAIR IOR TAIWAN AN I CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1