BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3950151 · Received July 22, 2014

    Report

    Report Number
    9616091-2014-01256
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT CROSSBRACE IS BROKEN AT THE WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428959 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other