BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED CORPORATION

    MDR report key: 225966 · Received May 28, 1999

    Report

    Report Number
    1720159-1999-00030
    Event Type
    Malfunction
    Date Received
    May 28, 1999
    Date of Event
    April 1, 1999
    Report Date
    May 3, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS A BREAST IMPLANT. THE DOCTOR GOT A MINOR BURN ON THE HAND AND THE PATIENT GOT A MINOR BURN ON THE NIPPLE. THE UNIT WAS SET ON 35, THE DOCTOR WAS USING NON-INSULATED TWEEZERS AND LEANING ON THE FOOT PEDAL. THIS REPORT IS FOR THE PATIENT'S BURN. REFER TO 1720159-1999-00028 FOR THE DOCTOR'S BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED CORPORATION ELECTROSURGICAL UNIT GEI ASPEN LABORATORIES, INC. EXCALIBUR PLUS PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NON-INSULATED TWEEZERS, MANUFACTURER UNK.