BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN

    MDR report key: 5479866 · Received September 10, 2004

    Report

    Report Number
    5479866
    Event Type
    Injury
    Date Received
    September 10, 2004
    Date of Event
    November 22, 2004
    Report Date
    August 10, 2004
    Manufacturer
    CODMAN
    Product Code
    GEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    FREER ELEVATOR BROKE DURING SURGICAL PROCEDURE, 2MM BY 1/2CM STAINLESS STEEL PIECE BROKE OFF AND EMBEDDED INTO PT'S SOFT TISSUE IN LEFT SHOULDER. PHYSICIAN WAS UNABLE TO RETRIEVE/REMOVE FROM PT'S LEFT SHOULDER. MFR #1226348-2004-00282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN FREER ELEVATOR GEG CODMAN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention