BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2923651 · Received January 22, 2013

    Report

    Report Number
    1525712-2013-00534
    Date Received
    January 22, 2013
    Date of Event
    November 30, 2012
    Report Date
    January 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. USER SAID DROVE OFF RAMP AND RAN INTO CURB THROWING HIM OUT OF CHAIR. EMS CALLED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31166 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Hospitalization