BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3173968 · Received June 17, 2013

    Report

    Report Number
    9616091-2013-01018
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER THE SPACER IN REAR OF ARM TO FLIP THE ARM BACK IS CRACKED. ARM GOES BEYOND THE BACK OF CHAIR WHEN FLIPPED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273808 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other