BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M UNIVERSAL ELECTROSURGICAL PAD

    MDR report key: 3360014 · Received September 13, 2013

    Report

    Report Number
    2110898-2013-00052
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    August 6, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    PMA / PMN Number
    K974279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER WAS NOT PROVIDED. WITHOUT THE LOT NUMBER 3M CANNOT DETERMINE THE DATE OF MANUFACTURE OR EXPIRATION DATE. TITLE AND POSITION OF REPORTER WAS NOT GIVEN. ACTUAL USED DEVICE WAS NOT RETURNED. MANUFACTURE DATE UNKNOWN. REPORTEDLY THE 3M UNIVERSAL ELECTROSURGICAL PAD WAS NOT IN FULL CONTACT WITH THE PATIENT. BASED ON THE INFORMATION PROVIDED IT IS DIFFICULT TO DETERMINE ROOT CAUSE OF THE BURN. THE BURN MAY HAVE OCCURRED IF THE PAD WAS NOT ADHERED PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN (B)(6) FEMALE PATIENT SUSTAINED A 1X1.5 INCH 2ND DEGREE BURN UNDER THE PAD FOLLOWING ELECTROPHYSIOLOGICAL MAPPING AND ABLATION OF THE ATRIAL FLUTTER. THE BURN WAS TREATED WITH SILVADENE AND WOUND CARE WAS CONSULTED. REPORTEDLY, THE PATIENT WAS IN A SUPINE POSITION FOR A 1 HOUR 30 MINUTE PROCEDURE WITH THE PAD ON THE LEFT FLANK. REPORTEDLY 3/4'S OF THE PLATE WAS ADHERED TO THE PATIENT AT THE TIME OF REMOVAL. THE GENERATOR WAS A BIOSENSE WEBSTER STOCKERT GENERATOR SET ON 70W AND A TEMPERATURE OF 60 DEGREE CELSIUS. THE GENERATOR WAS EVALUATED BY THE BIOMED AND CLEARED ALL TESTS. THE ACTIVE ELECTRODE WAS A NAVISTAR DS 8 MM F ABLATION AND WAS ACTIVATED FOR 13 MINUTES 54 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461210 3M UNIVERSAL ELECTROSURGICAL PAD 878.440 ELECTROSURGICAL ACCESSORY GEI 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other