BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVAID PRODUCT, INC.

    MDR report key: 23169438 · Received September 29, 2025

    Report

    Report Number
    2022883-2024-00001
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 20, 2024
    Report Date
    September 26, 2025
    Manufacturer
    CONVAID PRODUCTS LLC
    Product Code
    IOR
    PMA / PMN Number
    K140416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RETROSPECTIVE REVIEW OF COMPLAINTS, THIS REPORT WILL BE FILED IN ABUNDANCE OF CAUTION BECAUSE RECORD WAS NOT FOUND ON MAUDE DATABASE.

    Description of Event or Problem · 0

    I HAVE A KIDDO USING THIS PARTICULAR TREKKER THAT GOT LAUNCHED OUT OF HER SEAT AND BROKE HER TIBIA. MOM CLAIMS THE TILTING MECHANISM ISN'T FUNCTIONING PROPERLY. PATIENT WAS A NINE-YEAR-OLD FEMALE, THE CUSTOMER REPORTED THE CHAIR WAS PROVIDED FROM A DEALER IN HOUSTON IN WHICH THEY INDICATED THAT THERE WERE SOME BROKEN PARTS ON THE CHAIR BUT THEY WERE ABLE TO REPLACE THE PIECES ON THE CHAIR AND IT WAS SAFE TO USE. AFTER TWO WEEKS OF USE THE PATIENT WAS CATAPULTED OUT OF THE CHAIR BREAKING HER LEFT LEG. IT WAS REPORTED THE TILT SUPPORT BAR AND SCREWS WERE MISSING FROM THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943978 CONVAID PRODUCT, INC. TREKKER TRANSIT IOR CONVAID PRODUCTS LLC TREKKER TRANSIT

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Other