BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAFO KNEE ANKLE FOOT ORTHOSIS

    MDR report key: 16378137 · Received February 15, 2023

    Report

    Report Number
    16378137
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    July 10, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECKER ORTHOPEDIC APPLIANCE CO.
    Product Code
    IQI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A CALL FROM THE PATIENT STATING THAT HE FELL AND BROKE HIS RIGHT LEG, ABOVE THE KNEE, WHILE WEARING HIS RIGHT KNEE-ANKLE-FOOT ORTHOSIS (R-KAFO). THE PATIENT WAS ASKED IF THE DEVICE COULD BE DROPPED OFF BY HIS WIFE FOR SEQUESTERING, WHICH HE IS WILLING TO DO WHEN IT IS CONVENIENT FOR THEM TO DO SO. PATIENT WAS ASKED NOT TO DISCARD HIS KAFO DEVICE. THE PATIENT WAS ALSO INFORMED THAT I WILL NOTIFY HIS CLINICIAN AND HER SUPERVISOR SO THAT APPROPRIATE STEPS CAN BE TAKEN TO ADDRESS THE ISSUE. PATIENT WAS ASKED NOT TO DISCARD HIS KAFO DEVICE. NO MANUFACTURER RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968440 KAFO KNEE ANKLE FOOT ORTHOSIS ORTHOSIS, LIMB BRACE IQI BECKER ORTHOPEDIC APPLIANCE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Male Hospitalization| R