BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 20181284 · Received September 10, 2024

    Report

    Report Number
    1834241-2024-00002
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 10, 2024
    Manufacturer
    COLLEGE PARK INDUSTRIES, INC.
    Product Code
    ISY
    UDI-DI
    00195411451081
    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

    COLLEGE PARK WILL INVESTIGATE THE RETURNED ICON KNEE AND REPORT THE FINDINGS. COLLEGE PARK WILL CONTINUE TO MONITOR THE RETURNS FOR TRENDS.

    Description of Event or Problem · 0

    THE PATIENT WAS AT A RESTAURANT AND SHE CAUGHT HER TOE AND FELL. PATIENT WENT TO URGENT CARE. SHE DOES NOT HAVE ANY FRACTURES, JUST BUMPS AND BRUISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223583 ICON EXTERNAL PROSTHETIC KNEE ISY COLLEGE PARK INDUSTRIES, INC. IC MPKA 1000 08072024 00195411451081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other