BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3100736 · Received May 8, 2013

    Report

    Report Number
    1525712-2013-03617
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE ULTRA BRACKET ON A STEALTH HEADREST IS DEFECTIVE. THIS ISSUE MAY PREVENT A USER FROM OBTAINING THE NEEDED SUPPORT FOR THEIR MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200934 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other