BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1840813 · Received September 3, 2010

    Report

    Report Number
    1840813
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    METAL FINDINGS EMITTED FROM ARTHROSCOPIC SHAVER DURING KNEE SCOPE.====================== MANUFACTURER RESPONSE FOR ARTHROSCOPIC SHAVER======================HE WILL PUT OFFICIAL COMPLAINT IN TO COMPANY. ALL BOXES WITH THIS LOT# REMOVED FROM INVENTORY AS A PRECAUTION. REP WILL PICK UP DEFECTIVE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ARTHROSCOPIC SHAVER BLADE HRX SMITH AND NEPHEW * 50515812

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR