BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN & SHURTLEFF INC. A JOHNSON & JOHNSON CO.

    MDR report key: 468195 · Received June 23, 2003

    Report

    Report Number
    468195
    Event Type
    Injury
    Date Received
    June 23, 2003
    Date of Event
    May 7, 2003
    Report Date
    May 15, 2003
    Manufacturer
    CODMAN & SHURTLEFF INC. A JOHNSON & JOHNSON CO.
    Product Code
    GXP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRANIOPLASTIC AND TRACER MIXED PER PROTOCOL. SET UP PREMATURELY SO THAT TWO BATCHES HAD TO BE MIXED. THE PT HAD TO BE STUCK TWICE WITH TROCAR TO DELIVER TWO SMALL BATCHES CEMENT. EACH HARDENED VERY RAPIDLY. DR FEELS OUTCOME ADEQUATE, BUT UNABLE TO FULLY ASSESS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN & SHURTLEFF INC. A JOHNSON & JOHNSON CO. CRANIOPLASTIC GXP CODMAN & SHURTLEFF INC. A JOHNSON & JOHNSON CO. * 012503

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention