BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ELECTROSURGICAL GROUNDING PAD

    MDR report key: 2152911 · Received June 30, 2011

    Report

    Report Number
    2110898-2011-00088
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    February 5, 2004
    Report Date
    June 1, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    PMA / PMN Number
    K974553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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. CONCLUSIONS: NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFO FROM THE HOSPITAL RISK MANAGER AS WELL AS A BIOMED EMPLOYEE, REPORTING THAT A PT SUSTAINED A FOURTH DEGREE BURN TO THE RIGHT UPPER QUADRANT OF THEIR ABDOMEN DURING A RIGHT SHOULDER ARTHROSCOPIC PROCEDURE. THE BURN REPORTEDLY OCCURRED UNDER THE 3M UNIVERSAL ELECTROSURGICAL GROUNDING PAD, CATALOG NUMBER 9165. IT WAS NOTED THAT A WARMED BLANKET WAS PLACED ON THE PT POST-OP AND IT WAS AT THAT TIME THE BURNS WERE OBSERVED TO BE PINK WITH A SMALL BLISTER. THE BURN PROGRESSED TO THREE BLISTERED AREAS AND THE SEVERITY WAS DIAGNOSED AS A GRADE 4 BURN. THE BURN WAS TWO INCHES IN DIAMETER ALONG WITH TWO OTHER DIME SIZED BURNS REPORTED TO BE MORE THAN 1 CM DEEP (INTO ADIPOSE TISSUE). THE PT REQUIRED TWO SKIN GRAFT PROCEDURES - THE FIRST ONE INVOLVED A SKIN EXPANDER AND THE SECOND INVOLVED A SKIN GRAFT TO THE BURNED AREAS. 3M WAS NOT INFORMED OF THIS INJURY IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ELECTROSURGICAL GROUNDING PAD 878.400 ELECTROSURGICAL, CUTTING & COAG GEI 3M HEALTH CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention