BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 115353 · Received July 31, 1997

    Report

    Report Number
    115353
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    May 30, 1997
    Report Date
    June 12, 1997
    Manufacturer
    MEGA DYNE MEDICAL PRODUCTS, INC.
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PT UNDERGOING FULL-THICKNESS SKIN GRAFT FROM PT'S NECK WITH LOCAL/MAC ANESTHESIA WITH O2 TUBING (COVERED BY TOWEL). NEAR INCISION, AN EXTENDED "ARC/SPARK WAS NOTED. (A VALLEYLAB BOVIE UNIT AND HAND-CONTROLLED PIECE WERE BEING USED WITH A MEGADYNE MODIFIED EASY CLEAN NEEDLE TIP. A NON DISPOSABLE METAL NEURO-SUCTION TIP WAS ALSO BEING USED.) THE UNIT, HANDPIECE, AND TIP WERE IMMEDIATELY REMOVED FROM THE FIELD. NO PT INJURY. GENERATOR SETTINGS: CUTTING PURE 1 COAG 30

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * STERILE E-Z CLEAN 2 3/4" NEEDLE ELECTRODE MODIFIED GXZ MEGA DYNE MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention VALLEY BOVIE UNIT