BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 2177976 · Received July 6, 2011

    Report

    Report Number
    3032618-2011-00005
    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 Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT STATED THAT HE FELL OUT OF THE WHEELCHAIR BACKWARDS BUT WAS NOT INJURED. THE SUPPLIER STATED THAT A BOLT HAD SHEARED OFF.

    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