BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3961204 · Received July 28, 2014

    Report

    Report Number
    9616091-2014-01317
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 20, 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

    PER PROVIDER, THIS CHAIR WAS DELIVERED WITH A REAR WHEEL WHICH HAD A BROKEN SPOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439206 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other