BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1305548 · Received December 9, 2008

    Report

    Report Number
    1525712-2008-00137
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Report Date
    December 4, 2008
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ALLEGEDLY FEEL OUT OF HIS CHAIR. DEALER HAD SERVICED THE CHAIR, PERFORMED THE FIELD ACTION. MANUFACTURER CONTACTED THE CONSUMER. CONSUMER REPORTS NO FURTHER INCIDENTS.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGEDLY FELL OUT OF CHAIR SEVERAL TIMES DUE TO THE STRUTS NOT WORKING PROPERLY. NO SERIOUS INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1