BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 227874 · Received June 14, 1999

    Report

    Report Number
    1720159-1999-00035
    Event Type
    Malfunction
    Date Received
    June 14, 1999
    Date of Event
    May 3, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A C-SECTION, WHILE USING A CONMED PENCIL, #130319, THE BUTTON FELL IN THE ABDOMEN OF THE PT. THE BUTTON WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI ASPEN LABORATORIES, INC. CONMED PENCIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA