BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4002432 · Received August 12, 2014

    Report

    Report Number
    9616091-2014-01485
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, END-USER SPOUSE STATES THAT THE BRAKES DO NOT STOP THE CHAIR AT ALL, HAS ONLY HAD CHAIR FOR 4 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477546 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other