BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCE 10 BLADE

    MDR report key: 551027 · Received October 18, 2004

    Report

    Report Number
    551027
    Event Type
    Malfunction
    Date Received
    October 18, 2004
    Date of Event
    March 31, 2004
    Report Date
    October 18, 2004
    Manufacturer
    REGULATORY INSIGHT, INC.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON USING #10 BLADE BROKE DURING USAGE IN A KNEE. BOTH PIECES WERE IDENTIFIED AND REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCE 10 BLADE SURGICAL BLADE GFA REGULATORY INSIGHT, INC. * 0570403

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES