BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3981270 · Received August 5, 2014

    Report

    Report Number
    1525712-2014-04399
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    June 27, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE SEAT BELT IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457762 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN TDXSI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other