BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3260119 · Received August 1, 2013

    Report

    Report Number
    9616091-2013-01406
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    July 18, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A T4X24RDA MANUAL WHEELCHAIR HAD THE CASTER FORK STEM SNAP OFF AFTER THE USER HIT THE BOTTOM OF A HILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360836 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X24RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other