BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3033946 · Received April 3, 2013

    Report

    Report Number
    9616091-2013-00552
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER CONSUMER, BOTH CASTERS ARE CRACKED IN THE MIDDLE WHERE IT LOOK LIKE IT IS MORE WORN IN THE MIDDLE THEN IT IS ON THE OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136281 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 57 Other