BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS ARTHROSCOPIC SURGERY BLADE

    MDR report key: 4181827 · Received October 9, 2014

    Report

    Report Number
    MW5038599
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOREIGN DARK BROWN/GREEN LIQUID LEAKING FROM DEVICE AFTER IT WAS PLACED ON THE SHAVER HANDPIECE. DIAGNOSIS OR REASON FOR USE: ACL RECONSTRUCTION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635501 DYONICS ARTHROSCOPIC SURGERY BLADE DYONICS ARTHROSCOPIC SURGERY BLADE HRX SMITH AND NEPHEW 7205328 50771992

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR