BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 4023907 · Received August 13, 2014

    Report

    Report Number
    8020045-2014-00008
    Event Type
    Injury
    Date Received
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER, SAMPLES OR OTHER FURTHER INFO REGARDING THE PRODUCT INVOLVED HAVE BEEN MADE AVAILABLE TO US SO FAR, NO ANALYSIS COULD BE PERFORMED. WE ALSO LACK INFO ABOUT THE POSITION OF THE INJURY AND CAN THUS INLY SPECULATE WHETHER THE SYMPTOMS OBSERVED ARE THE CONSEQUENCES OF A BURN NECROSIS OR A PRESSURE NECROSIS. THE INFO PROVIDED ALSO INDICATES THAT THE IFU HAS NOT BEEN FOLLOWED. THE PT'S WEIGHT WAS REPORTED AS (B)(6), THE IFU LIMITS THE PARTICULAR MODEL TO PTS HEAVIER THAN 15.0. KG. THE POSITION OF THE ELECTRODE ON THE PT'S CALF ALSO IS NOT IN LINE WITH THE IFU, WHICH RECOMMENDS "AN UPPER ARM OR THIGH". HOWEVER, FOR LACK OF INFO WE CANNOT ASSESS WHETHER THIS HAS BEEN RELEVANT FOR THE INCIDENT OR NOT. AN EMAIL DATED (B)(6) 2012, THE INITIAL REPORTER (B)(4) INFORMED US THAT "(...) THIS COMPLAINT IS IN THE PROCESS OF BEING CLOSED FOR IN PRODUCT RETURNED AND NO ADD'L INFO PROVIDED. WE HAVE TRIED ON NUMEROUS OCCASIONS TO REACH THEM BUT NO RESPONSE.". THIS REPORT IS SENT TO FDA AS A PRECAUTION. WE ARE NOT ENTIRELY SURE A REPORTABLE EVENT HAS ACTUALLY HAPPENED AS THE INFO ABOUT THE SKIN TREATMENT NECESSARY WAS NOT SPECIFIED.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED BY (B)(4) MEDICAL PRODUCTS USA ABOUT AN INCIDENT WITH AN ELECTROSURGICAL DISPERSIVE GROUNDING PLATE. THE INITIAL REPORT STATED THE FOLLOWING INFO: "DR. WAS PERFORMING AN ACCESSORY PATHWAY ABLATION (EP LAB) ON A (B)(6) MONTH OLD PT (WEIGHT (B)(6)) WHICH RECEIVED BLISTERING AND REDNESS AFTER USING OUR 0855C. THE PAD WAS PLACED ON THE PTS CALF. DR. STATED IT WAS A SECOND DEGREE BURN, THE BLISTERING AND REDNESS WAS NOT NOTICED UNTIL 2 DAYS POST PROCEDURE." NO FURTHER INFO ON THE PT, THE GENERATOR MODEL, THE POWER SETTINGS, THE PT INJURY, ITS PRECISE LOCATION AND THE TREATMENT HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482909 MEGADYNE ELCTROSURGICAL DESPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RSW271A30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Other