BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2832737 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02156
    Date Received
    November 14, 2012
    Date of Event
    July 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER'S LEGAL REPRESENTATIVE THAT THE ARM OF AN UNKNOWN MODEL AND SERIAL NUMBERS OF A POWER WHEELCHAIR HAD FALLEN OFF, RESULTING IN THE PATIENT BEING UNABLE TO CONTROL THE UNIT, WHICH COLLIDED WITH A METAL POLE, AND SHE GOT INJURED. THERE IS NO INFORMATION AVAILABLE ON SEVERITY OF THE INJURIES, AND IF THE PATIENT SOUGHT MEDICAL CARE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other