BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE X

    MDR report key: 23750927 · Received December 8, 2025

    Report

    Report Number
    3032618-2025-00007
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 8, 2025
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    UDI-DI
    00853316008129
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT INDICATES THE DEALER HAD PERFORMED SOME ADJUSTMENTS ON THE MWC TO WHERE THEY LOWERED THE STF HEIGHT. REPORTS WHEN THE CLIENT LEFT THE FACILITY, THE DEVICE WAS EQUIPPED WITH ANTI-TIP SUPPORTS. REPORT INDICATED THE END-USER HAVING REMOVED THE ANTI-TIP SUPPORTS SHORTLY AFTER HAVING RECEIVED THE CHAIR, AND WHEN PERFORMING A WHEELIE, THE DEVICE FELL OVER BACKWARD CAUSING THE END-USER TO STRIKE THEIR HEAD ON THE PAVEMENT. REPORT INDICAETD THE END-USER WAS TKEN TO THE HOSPITAL, BUT DID NOT PROVIDE ANY INFORMATION AS TO THE EXTENT OF INJURY, OR IF ANY MEDICAL INTERVENTION WAS REQUIRED. NO CLAIMS OR ALLEGATION OF ANY PRODUCT MALFUNCTION HAVING OCCURRED WITH ALL INDICATIONS OF INADVERTENT USE ERROR AS BEING THE CAUSE.

    Description of Event or Problem · 0

    RECEIVED REPORT THAT WHILE THE END-USER WAS ATTEMPTING TO LIFT THE FRONT END OF THEIR MANUAL WHEELCHAIR VIA A WHEELIE, THE CHAIR REPORTEDLY FLIPPED OVER BACKWARD WHICH RESULTED IN THE END-USER STRIKING THEIR HEAD ON THE GROUND RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113649 TILITE X MANUAL WHEELCHAIR IOR TISPORT, LLC X 00853316008129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization