BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCISE CEMENT SCULPS KIT

    MDR report key: 19395 · Received February 3, 1995

    Report

    Report Number
    MW1005015
    Event Type
    Malfunction
    Date Received
    February 3, 1995
    Date of Event
    September 20, 1994
    Report Date
    January 26, 1995
    Manufacturer
    SMITH & NEPHEW RICHARDS, INC.
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTIFIED MFR 10/3/94 OF BREAKAGE OF A BLUE CEMENT CURRETTE. THE BROKEN PIECE REMAINS MISSING. NO PT INJURY IS KNOWN AT THIS TIME. RADIOLOGY FILMS ARE NEGATIVE FOR FOREIGN OBJECT. UPON INVESTIGATION OF THE BOX, IT WAS NOTICED THAT ANOTHER CURRETTE, STILL PACKAGED, WAS BROKEN. BOTH HAVE THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCISE CEMENT SCULPS KIT LZV SMITH & NEPHEW RICHARDS, INC. ID54640

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other UNUSED PACKAGE RETURNED 9/94.