BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEN20 CONDUCTIVE

    MDR report key: 246747 · Received October 18, 1999

    Report

    Report Number
    1718791-1999-00001
    Event Type
    Other
    Date Received
    October 18, 1999
    Date of Event
    September 1, 1999
    Report Date
    October 13, 1999
    Manufacturer
    WEAVER & CO
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    AUDIOLOGY DEPT DID AN "ABR"TEST (AUDIOLOGY) ON NEWBORN GIRL. USED TEN20 CONDUCTIVE AN NUPREP FOR 10-15 MINS ON 3 ELECTRODE SITES. GROUND ELECTRODE SITE DEVELOPED "BURN" AREA OF 2ND DEGREE WITH DESCRIBED CTR OF 3RD DEGREE. SCAB ON FOREHEAD 1.3 CM BY 0.7 CM. LAST SEEN BY PHYSICIAN ON 9/15/99. SCAB AT THAT TIME DIMINISHING AND SCAB SEPARATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN20 CONDUCTIVE CONDUCTIVE AND ADHESIVE PASTE GYB WEAVER & CO NA DEC 2001 02

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DAY Other BIO-LOGIC NAVIGATOR (TESTING EQUIPMENT).