BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3951969 · Received July 23, 2014

    Report

    Report Number
    9616091-2014-01270
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 17, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE WELD AT THE POINT OF THE BACK CANE MEETING THE FRAME HAS BROKEN. NO INJURIES NOTED 7857HF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431011 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other