BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4220259 · Received November 3, 2014

    Report

    Report Number
    1525712-2014-07537
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702050 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M41BB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other