BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4952717 · Received September 20, 2013

    Report

    Report Number
    9612393-2013-00091
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Report Date
    September 20, 2013
    Manufacturer
    TAIWAN AN I CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: (B)(6) 2012, RBS - THE DEALER REPORTED THAT THE IN86AHANFR MECHANICAL WHEELCHAIR HAD BOTH PIVOT LINKS BROKEN. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478408 MECHANICAL (MANUAL) WHEELCHAIR WHEELCHAIR IOR TAIWAN AN I CO.,LTD. IN86AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1