BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNIVERSAL ELECTROSURGICAL PAD

    MDR report key: 2926199 · Received January 14, 2013

    Report

    Report Number
    2110898-2013-00001
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    October 3, 2012
    Report Date
    December 13, 2012
    Manufacturer
    3M HEALTH CO
    Product Code
    GEI
    PMA / PMN Number
    974553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WRONG 3M PRODUCT WAS USED WITH THE GENERATOR CLAIMING TO HAVE REM. LABELING FOR PRODUCT INCLUDES THE FOLLOWING WARNING AND INSTRUCTIONS FOR USE: WARNING: IMPROPER USE OF UNIVERSAL ELECTROSURGICAL PADS CAN CAUSE ELECTROSURGICAL BURNS OR PRESSURE NECROSES. FOR PT SAFETY, FOLLOW ALL OF THE INSTRUCTIONS BELOW. FAILURE TO FOLLOW ANY OF THESE INSTRUCTIONS INCREASES THE RISK OF ELECTROSURGICAL BURNS OR PRESSURE NECROSES. USE APPROPRIATE PADS, EQUIPMENT, AND ACCESSORIES. DOES THE ELECTROSURGICAL GENERATOR HAVE A CONTACT QUALITY MONITORING SYS (EG REM, ARM, NESSY)? (LABELING INCLUDES ILLUSTRATION OF WHICH STYLE OF PAD TO USE WITH GENERATOR HAVING CQM).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FEMALE PT SUSTAINED SECOND AND THIRD DEGREE BURNS, ONE MEASURING 3CM AND ONE MEASURING 4 CM, DURING A COLPOSCOPY AND BIOPSY PROCEDURE. REPORTEDLY THE BURNS OCCURRED ON THE EDGE OF THE PAD, LOCATED ON THE LEFT INNER THIGH, AND THEY WERE TREATED BY A PLASTIC SURGEON WITH FITOESTIMULINA (TRITICUM VULGARE AND FENOXIETANOL). THE PT REPORTED PAIN AS SOON AS THE SURGEON ACTIVATED THE ELECTROCAUTERY, THE PROCEDURE WAS IMMEDIATELY STOPPED AND COULDN'T BE PERFORMED. THE GENERATOR USED WAS NOTED TO HAVE CONTACT QUALITY MONITORING (CQM) CAPABILITY. THE 3M PRODUCT USED ((B)(4)) WITH THE GENERATOR IS NOT INTENDED FOR USE ON A GENERATOR THAT HAS CQM. 3M INSTRUCTIONS FOR USE INCLUDES INFO ON PRODUCT USE WITH GENERATORS THAT HAVE CQM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20888 3M UNIVERSAL ELECTROSURGICAL PAD (GEI) ELECTROSURGICAL ACCESSORY GEI 3M HEALTH CO NA 2015-02 DT

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other