BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNIVERSAL ELECTROSURGICAL PAD

    MDR report key: 4223738 · Received October 29, 2014

    Report

    Report Number
    2110898-2014-00073
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 3, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    PMA / PMN Number
    K974553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF A FLAMMABLE CHLORHEXIDINE SOLUTION WAS ON THE SKIN UNDER THE ELECTROSURGICAL PAD WHEN THE GENERATOR WAS STARTED AND ELECTROCAUTERY/PENCIL WAS INITIATED, THIS COULD GENERATE A SPARK WHICH WOULD EXPLAIN THE 2ND DEGREE BURN. BURN(S) - INJURY TO TISSUES CAUSED BY CONTACT WITH DRY HEAT, MOIST HEAT, FLAMES, CHEMICALS, ELECTRICITY, FRICTION OR RADIANT AND ELECTROMAGNETIC ENERGY. A FIRST DEGREE BURN IS ASSOCIATED WITH REDNESS, A SECOND DEGREE BURN WITH VESICATION AND THIRD DEGREE BURN WITH NECROSIS THROUGH THE ENTIRE SKIN. SPARK - ISSUE ASSOCIATED WITH A FLASH OF LIGHT RELATED TO AN ELECTRICAL DISCHARGE IN AN UNEXPECTED LOCATION. METHOD: LABELING EVAL - REVIEWING ALL LABELING (INCLUDING INSTRUCTIONS FOR USE, MANUALS AND PACKAGING) FOR LANGUAGE RELATED TO REPORTED DEVICE PROBLEMS; NO TESTING METHODS PERFORMED - TESTING WAS NOT PERFORMED ON THE DEVICE. CONCLUSION: HUMAN FACTORS ISSUE, USER ERROR CAUSED OR CONTRIBUTED TO EVENT - THE INTERACTION BETWEEN THE DEVICE AND THE USER CAUSED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A 3M ELECTROSURGICAL PAD WAS PLACED ON THE THIGH OF FEMALE PT PRIOR TO A BREAST IMPLANT SURGERY. BEFORE THE SURGERY STARTED, THE SURGEON ALLEGED "SMALL EXPLOSIONS IN THE ELECTROCAUTERY PAD" OCCURRED. THE PT ALLEGEDLY RECEIVED A 2ND DEGREE BURN (12 CM X 5 CM) UNDER THE PAD. THE FAMILY WAS NOTIFIED. A DIFFERENT GENERATOR AND A NEW PAD WITH THE SAME LOT NUMBER WERE USED; THE SURGERY CONTINUED WITHOUT INCIDENT. MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT OF THE ALLEGED BURN. THE PT WAS DISCHARGED WITH F/U FOR DRESSING CHANGES. ADD'L MEDICAL INFO RECEIVED ON (B)(6) 2014 BY NURSE INDICATED THE SURGICAL SITE WAS PREPARED WITH A CHLORHEXIDINE SOLUTION. IT IS NOT POSSIBLE TO RULE OUT CONTACT OF THE SOLUTION WITH THE SKIN AT THE ELECTROSURGICAL PAD SITE BEFORE THE PAD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691258 3M UNIVERSAL ELECTROSURGICAL PAD ELECTROSURGICAL AND ACCESSORIES GEI 3M HEALTH CARE NA 2017-05 GF

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other