BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2981861 · Received February 27, 2013

    Report

    Report Number
    9616091-2013-00313
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER THE RIGHT SIDE FRAME ARM SOCKET HAS CRACKED AWAY FROM THE CHAIR SO IT NO LONGER SUPPORTS THE ARM. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83747 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T424RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other