BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 231877 · Received July 14, 1999

    Report

    Report Number
    231877
    Event Type
    Malfunction
    Date Received
    July 14, 1999
    Date of Event
    July 1, 1999
    Report Date
    July 12, 1999
    Manufacturer
    CON-MED/ASPEN LABS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDICAL RECORD REVIEWED 7-12-99. PT IN OPERATING ROOM FOR REVISION OF LEFT UPPER ARM ARTERIOVENOUS GORETEX SHUNT WITH THROMBECTOMY. PER OPERATING ROOM RECORDS, "BOVIE PAD INTACT; BOVIE MACHINE SETTING COAG 20 AND CUT 20; SKIN EDGE LEFT UPPER ARM BURNED 1.5 CM." BOVIE PENCIL REMAINED ACTIVE WHILE BUTTON WAS NOT BEING PRESSED. UNABLE TO DETERMINE EXACT LOT NUMBER FROM PACKAGING. SUBMITTING 4 LOT NUMBERS FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BOVIE GEI CON-MED/ASPEN LABS 49040935, 49030747, OR (MORE) *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other