BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5"

    MDR report key: 81135 · Received April 2, 1997

    Report

    Report Number
    1423537-1997-00058
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    February 19, 1997
    Report Date
    March 10, 1997
    Manufacturer
    SITE-1923569-V. MUELLER/SURGICAL GROUP
    Product Code
    GEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE COMPLETION OF THE SEPTAL PLASTY CASE, THE SURGEON NOTICED THAT A SMALL PIECE OF THE ELEVATOR WAS MISSING. IT IS UNKNOWN WHETHER IT WAS RETAINED IN THE PT OR LOST ELSEWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREER SEPTUM ELEVATORS DOUBLE ENDED 7.5" SEPTUM ELEVATOR GEG SITE-1923569-V. MUELLER/SURGICAL GROUP RH750 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other