BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3250510 · Received July 26, 2013

    Report

    Report Number
    9616091-2013-01329
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 10, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE BRAKES ON THE T4X22RDA MANUAL WHEELCHAIR HAVE WORN PREMATURELY. THE REPORTER ALLEGED THE PREMATURE WEAR WAS ATTRIBUTABLE TO THE USER'S PRE-EXISTING MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350939 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X22RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other