BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4211403 · Received October 29, 2014

    Report

    Report Number
    1525712-2014-07378
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT AXLE BROKE AT A WELD ON THE M91 POWER CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693162 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M91

    Patients

    Seq Age Sex Outcome Treatment
    1 Other