BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL UNIT, VALLEYLAB

    MDR report key: 1323263 · Received February 18, 2009

    Report

    Report Number
    1323263
    Event Type
    Injury
    Date Received
    February 18, 2009
    Date of Event
    November 7, 2008
    Report Date
    February 2, 2009
    Manufacturer
    COVIDIEN EDD
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT STAB PHLEBECTOMIES OF RECURRENT VARICOSITIES OF LEFT SAPHENOUS VEIN IN AMBULATORY SURGERY. GROUNDING PAD APPLIED TO LEFT THIGH AND ATTACHED TO ELECTROCAUTERY MACHINE. SKIN INTACT POSTOPERATIVELY. IN PACU, PT COMPLAINED OF BURNING OF THE THIGH. DISCHARGED WITH LEG WRAPPED IN CIRCUMFERENTIAL BANDAGE. BLISTERS NOTED 48 HOURS LATER WHEN PT REMOVED BANDAGE. BURN AREA MATCHED SIZE AND CONTOUR OF GROUNDING PAD. BURN PROGRESSED TO FULL THICKNESS THERMAL INJURY NECESSITATING SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNIT, VALLEYLAB ELECTROCAUTERY GEI COVIDIEN EDD FORCE FX-C *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention MANUFACTURER: 3M MEDICAL| 3M UNIVERSAL ELECTROSURGICAL GROUNDING PAD