BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3112670 · Received May 14, 2013

    Report

    Report Number
    9616091-2013-00811
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE L BRACKET ON THE CROSSBAR FOR A T424RFA MANUAL WHEELCHAIR BREAKING ON THE RIGHT HAND SIDE. THIS COMPROMISES THE SEATING SUPPORT OF THE CHAIR AND CREATES THE POTENTIAL FOR A FALLING INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212786 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T424RFA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Other