BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2GX

    MDR report key: 8237866 · Received January 10, 2019

    Report

    Report Number
    3032618-2019-00001
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 12, 2018
    Report Date
    January 10, 2019
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET SPECIFICATIONS AS ORDERED BY THE DEALER WHEN IT LEFT THE FACILITY. THE DEALER AND/OR A THERAPIST MEASURE THE USER FOR A WHEELCHAIR. TISPORT AS THE MANUFACTURER BUILDS THE CHAIR BASED ON THE MEASUREMENTS PROVIDED TO US FROM THE DEALER AND/OR THERAPIST.

    Description of Event or Problem · 1

    AS DESCRIBED BY THE DEALER, THE CUSTOMER'S WHEELCHAIR ALLEGEDLY TIPPED FORWARD CAUSING THEM TO FRACTURE THEIR LEG. WE HAVE NOT BEEN PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE INJURY, OTHER THAN THESE ALLEGATIONS, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26404 2GX WHEELCHAIR IOR TISPORT, LLC 2GX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization