BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3872707 · Received June 13, 2014

    Report

    Report Number
    9616091-2014-01022
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BEARINGS ARE LOOSE DUE TO BEING RUSTED OUT IN THE FRONT RIGHT FORK OF THE TRSX58FBF STANDARD WHEEL CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349022 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX58FBF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other