BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M UNIVERSAL ELECTROSURGICAL GROUNDING PAD

    MDR report key: 2033008 · Received March 16, 2011

    Report

    Report Number
    2110898-2011-00027
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    PMA / PMN Number
    K974553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE. NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFO THAT DURING A AAA WOUND DEBRIDEMENT AND CLOSURE, A (B)(6) MALE PT SUSTAINED A 3CM X 5CM, 3RD DEGREE BURN TO THE RIGHT LATERAL THIGH, CAUSED BY A 3M UNIVERSAL PRE-CORDED SPLIT GROUNDING PAD. THE PT WAS TREATED WITH SILVADENE AND COVERED WITH STERILE GAUZE. IT WAS REPORTED THAT THE SURGEON MADE TWO REQUESTS TO INCREASE THE POWER. THE ALARM SOUNDED, AND AT THE END OF THE PROCEDURE, THE NURSE NOTED A BURNED SMELL. ACCORDING TO THE HEAD NURSE, 60% OF THE PAD (NEAR THE TAB END) WAS ADHERED TO THE PT AT THE END OF THE PROCEDURE. THE BURN OCCURRED UNDER THE OPPOSITE END OF THE PAD, THE SIDE OF THE PAD WHICH HAD LIFTED. THE NURSE ALSO STATED, THERE WAS NO FLUID POOLED IN THE AREA OF THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M UNIVERSAL ELECTROSURGICAL GROUNDING PAD 878.4400 ELECTROSURGICAL, CUTTING & COAG GEI 3M HEALTH CARE NA 2013-07 KF

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention