BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2912583 · Received January 13, 2013

    Report

    Report Number
    9616091-2013-00071
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A DEALER HAS CALLED AND REPORTED THAT THE RIM OF CASTER IS BENT. IT WAS LEARNED THE END USER HAD BOUGHT THIS DEVICE SECOND HAND AND THIS EVENT WAS NOTED TO BE PRESENT AT THAT TIME BY THE END USER. THE DEALER CALLED FOR A REPLACEMENT PART TO FIX THE MANUAL WHEELCHAIR CASTER RIM. REPAIR WILL BE COMPLETED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19439 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other