BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ELECTROSURGICAL PATIENT PLATE, STANDARD, NON CORDED

    MDR report key: 1171083 · Received September 18, 2008

    Report

    Report Number
    2110898-2008-00024
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 16, 2008
    Manufacturer
    3M HEALTHCARE, 3M CO.
    Product Code
    ODR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IN 3M PRODUCT INSTRUCTIONS FOR USE, IT IS STATED THAT "TO REDUCE THE RISK OF BURNS AND PRESSURE NECROSES: DO NOT APPLY UNIVERSAL PAD WHERE FLUIDS MAY POOL". 3M HAS REVIEWED THE PICTURES OF INJURY SITE OF THE PATIENT PROVIDED BY THE USER FACILITY. THE PICTURE SHOWS THAT THE PLATE WAS CONTAMINATED WITH SURGICAL PREP SOLUTION WHICH INDICATED THE CONDUCTIVE SOLUTION WENT UNDER THE PATIENT PLATE THAT WOULD CAUSE THE BURN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FEMALE PATIENT SUSTAINED A 3RD DEGREE BURN TO THE ANTERIOR THIGH DURING CHILDBIRTH AND THAT IT WAS TREATED BY WOUND CARE. PHOTOS OF THE USED PLATE SHOW A NARROW BLACKENED AREA ADJACENT TO THE CONDUCTIVE GEL ON THE END OF THE PLATE OPPOSITE THE TAB END. ETIOLOGY OF THE BURN IS UNKNOWN SINCE INFORMATION REGARDING GENERATOR SETTINGS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ELECTROSURGICAL PATIENT PLATE, STANDARD, NON CORDED DISPERSIVE ELECTRODE ODR 3M HEALTHCARE, 3M CO. NA 2010-07 KL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NONE REPORTED