BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 2177989 · Received July 6, 2011

    Report

    Report Number
    3032618-2011-00008
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    TISPORT, LLC.
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUPPLIER STATED THAT THE PT FELL OUT OF THE CHAIR AND WENT TO SEE A DOCTOR. THE SUPPLIER STATED THAT THE BACK IS "BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TILITE ZRA SERIES 2 WHEELCHAIR, MECHANICAL IOR TISPORT, LLC. ZRA SERIES 2

    Patients

    Seq Age Sex Outcome Treatment
    1