BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2923583 · Received January 22, 2013

    Report

    Report Number
    9616091-2013-00103
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 19, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    DEALER STATES 05CM619857 ADVISED EACH WHEEL HAD ONE CRACKED SPOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31356 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other