BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3081690 · Received April 29, 2013

    Report

    Report Number
    1525712-2013-03314
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.CONSUMER ALLEGES THE COVED SPACER BROKE IN HALF.MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185623 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other