BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE 2GX

    MDR report key: 12900956 · Received November 30, 2021

    Report

    Report Number
    3032618-2021-00009
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 30, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTS PROVIDED TO TILITE CLAIM AS THE END-USER WAS ATTEMPTING TO TRANSFER FROM THEIR MOTOR VEHICLE TO THE 2GX MANUAL WHEELCHAIR, REPORTS INDICATE THE END-USER'S FOOT SLIPPED WHICH CAUSED THEM TO LOSE BALANCE AND FALL TO THE GROUND. THE ENSUING FALL REPORTEDLY RESULTED WITH THE END-USER SUSTAINING A FRACTURE TO ONE OF THEIR LEGS (UNSPECIFIED AS TO WHICH LEG OR BONE). NO ALLEGATIONS OR CLAIMS WERE MADE INDICATING THE DEVICE MALFUNCTIONED OR DEVIATED IN ANY WAY TO HAVE CONTRIBUTED TO THIS EVENT. ALL REPORTS RECEIVED INDICATE THIS REPORTED INCIDENT WAS THE RESULT OF INADVERTENT USE ERROR IN THE LOSS OF BALANCE DURING A TRANSFER. THE DHR FOR THIS DEVICE WAS REVIEWED AND WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    TILITE RECEIVED REPORT CLAIMING AS THE END-USER WAS ATTEMPTING TO TRANSFER FROM THEIR MOTOR VEHICLE INTO THE SEATING OF THE MANUAL WHEELCHAIR, THE END-USER REPORTED THEIR FOOT SLIPPED IN PROCESS OF TRANSFERRING AND THIS CAUSED THEM TO LOSE BALANCE AND FALL TO THE GROUND WHERE THEY SUSTAINED AN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789350 TILITE 2GX MANUAL WHEELCHAIR IOR TISPORT, LLC 2GX

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization