BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 2177975 · Received July 6, 2011

    Report

    Report Number
    3032618-2011-00006
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SUPPLIER STATED THAT THE PT STATED THAT HE FELL OUT BACKWARDS AND IS SORE AND BRUISED. THE SUPPLIER STATED THAT THE BACKREST "BROKE".

    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