BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3072039 · Received April 22, 2013

    Report

    Report Number
    9616091-2013-00683
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    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

    (B)(4). THE DEALER REPORTED THAT THE TREX2 MECHANICAL WHEELCHAIR HAD THE WHEELS CHANGED BECAUSE THE REAR RIGHT WHEEL COULD BE ROTATED MANUALLY , AND AFTERWARDS THE ISSUE REMAINED, ALTHOUGH THE FRAME COULD NOT BE VISIBLY DETECTED TO BE BENT. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171798 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other