BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZRA SERIES 2

    MDR report key: 5788365 · Received July 12, 2016

    Report

    Report Number
    3032618-2016-00003
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    February 17, 2016
    Report Date
    June 30, 2016
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER AND/OR A THERAPIST MEASURE THE USER FOR A WHEELCHAIR. TILITE AS THE MANUFACTURER BUILDS A CHAIR BASED ON THE MEASUREMENTS PROVIDED TO US FROM THE DEALER AND/OR THERAPIST. TILITE DOES NOT CHOOSE THE STYLE OR MEASUREMENT OF THE FRONT FRAME TAPER. THIS INFORMATION COMES FROM THE USER. TRAINING ON HOW TO USE THE CHAIR ALSO COMES FROM THE DEALER AND/OR THERAPIST AS WELL AS HELP FROM THE USER MANUAL, PROVIDED WITH EACH TILITE CHAIR. THE RESULT OF THE INCIDENT WAS AN ACCIDENT BASED ON THE USER'S ACTIONS. THE DHR FOR THIS DEVICE WAS REVIEWED AND THE CHAIR WAS BUILT ACCORDING TO SPECIFICATION. USER MISUSE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS TRANSFERRING OUT OF HER TILITE CHAIR, GOT HER FOOT CAUGHT IN THE FRONT OF THE FRAME. SHE PROCEEDED TO TWIST AND BREAK HER LEG. SHE COMPLAINED THE FRONT TAPER OF THE CHAIR IS TOO WIDE AND HINDERED WITH HER TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440119 ZRA SERIES 2 WHEELCHAIR MECHANICAL IOR TISPORT, LLC ZRA SERIES 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention