BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3830975 · Received May 23, 2014

    Report

    Report Number
    9616091-2014-00928
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RUBBER AROUND LEFT CASTER WILL COME OFF OF THE T422HD280 STANDARD WHEEL CHAIR WHEN END USER GOES OVER ROUGH PAVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307525 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422HD280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other