BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4100953 · Received September 19, 2014

    Report

    Report Number
    9616091-2014-01925
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGED THAT THE WASHERS ARE BREAKING ON BACK OF THE CHAIR AND THE STRAPS ON THE SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584252 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX LTTB19FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other