BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREER SEPTUM ELEVATOR

    MDR report key: 5410368 · Received September 16, 2004

    Report

    Report Number
    1226348-2004-00282
    Event Type
    Malfunction
    Date Received
    September 16, 2004
    Date of Event
    July 22, 2004
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS BEEN ADVISED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE FREER SEPTUM ELEVATOR IS AN INSTRUMENT THAT IS INTENDED FOR USE IN NASAL SURGERY. HOWEVER, THE CUSTOMER REPORTS A PORTION BROKE OFF AND BECAME EMBEDDED IN THE PT'S SHOULDER. THE TYPE OF SURGICAL PROCEDURE FOR WHICH THIS NASAL ELEVATOR WAS DETERMINED. THE COMPLAINT CANNOT BE VERIFIED. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    PER (B)(4), FREER ELEVATOR BROKE DURING SURGICAL PROCEDURE. A 2MM BY 1/2CM STAINLESS STEEL PIECE BROKE OFF AND EMBEDDED IN PT'S SOFT TISSUE IN LEFT SHOULDER. PHYSICIAN WAS UNABLE TO RETRIEVE/REMOVE FROM PT'S LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREER SEPTUM ELEVATOR ELEVATOR, SURGICAL, GENERAL, PLASTIC SURGERY GEG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other