BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 2177712 · Received July 1, 2011

    Report

    Report Number
    3032618-2011-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BACKREST PIVOT BOLT FAILURE. THE PT FELL OUT OF WHEELCHAIR BACKWARDS. THE PT WAS HOSPITALIZED BRIEFLY AND DISCHARGED. ACCORDING TO HIS ATTORNEY, IT IS UNCLEAR IF THE HOSPITALIZATION RELATED TO THE FALL OR TO HIS RECENT SPINAL CORD INJURY.

    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 Other