BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED MACROLYTE INFANT DISPER ELECT.

    MDR report key: 250413 · Received November 22, 1999

    Report

    Report Number
    1317214-1999-00060
    Event Type
    Other
    Date Received
    November 22, 1999
    Date of Event
    October 18, 1999
    Report Date
    November 18, 1999
    Manufacturer
    CONMED CORP.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 8 MONTH OLD BABY, UNDERGOING A "CARDIO-VASCULAR SURGERY OF PEDIATRIC" RECEIVED A BURN ON THE LEFT HIP-5CM IN LENGTH OVERALL. WORKING TIME FOR THE PROCEDURE WAS 5 HOURS WITH VERY LITTLE USE OF THE ELECTRO-STATIC UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED MACROLYTE INFANT DISPER ELECT. DISPERSIVE CONDUCTIVE ADHESIVE ELECTRODE JOS CONMED CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other EXCALIBRE PLUS PC ESU (10/28/1999 TO 10/28/1999).