BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA AGGRESSIVE PLUS

    MDR report key: 1943508 · Received December 22, 2010

    Report

    Report Number
    1943508
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE SHAVER BLADE BROKE OFF WHILE THE SURGEON WAS DOING AN ARTHROSCOPY ON THE PATIENT'S RIGHT KNEE. THE SURGEON HAD TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT'S RIGHT KNEE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SURGEON FELT THAT THE SHAVER BROKE BECAUSE IT WAS RE-PROCESSED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA AGGRESSIVE PLUS ARTHROSCOPE, BLADE HRX ASCENT HEALTHCARE SOLUTIONS 375-544-000 1316606

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NO OTHER THERAPIES