BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4952718 · Received September 20, 2013

    Report

    Report Number
    9612393-2013-00092
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: (B)(6) 2012 - RBS - IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE IN66AHANFR MECHANICAL WHEELCHAIR CASTER HOUSING WAS NOT HOLDING, AND WAS BENDING UNDERNEATH THE UNIT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478424 MECHANICAL (MANUAL) WHEELCHAIR WHEELCHAIR IOR TAIWAN AN I CO.,LTD. IN66AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1