BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 4364505 · Received December 17, 2014

    Report

    Report Number
    8020045-2014-00017
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    October 1, 2014
    Report Date
    December 17, 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

    THE RETAINED SAMPLES HAVE BEEN VISUALLY AND TESTED ELECTRICALLY AND THERMALLY. MECHANICAL TESTS WERE PERFORMED ON RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. OUR CUSTOMER MEGADYNE MEDICAL PRODUCTS INC. PROVIDED THE FOLLOWING INFORMATION: "WE HAVE RECEIVED THE PAD INVOLVED IN THIS EVENT AND I WILL BE SENDING IT TO YOU". WE ARE WAITING FOR THE INVOLVED SAMPLE FOR FURTHER INVESTIGATIONS. ADDITIONALLY WE ARE REQUESTING FURTHER INFORMATIONS ON THE SKIN PREPARATION, THE PATIENT INJURY, ITS PRECISE LOCATION AND THE ORIENTATION OF THE ELECTRODE ON THE PATIENT. WE WILL CONTINUE TO ASK FOR FURTHER INFORMATION AND WILL RELAY ANY INFORMATION AND FURTHER CONCLUSIONS IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A 2 HOURS BREAST REDUCTION WAS PERFORMED AT (B)(6) USA. A REM EQUIPPED VALLEYLAB ELECTROSURGICAL GENERATOR (FORCE TRIAD) AND A MONITORING DISPERSIVE ELECTRODE (MODEL RSW271A30) WERE USED. THE PATIENT POSITION WAS DESCRIBED AS SUPINE POSITION AND SHE WAS NOT REPOSITIONED. THE BODY AND SKIN TYPE OF THE PATIENT WAS DESCRIBED AS UNKNOWN. ACCORDING TO THE QUESTIONNAIRE IT IS UNKNOWN WHETHER SKIN CLEANING, SHAVING, DISINFECTION AND DRYING WERE PERFORMED. IT WAS STATED THAT NO OINTMENT HAS BEEN USED. THE ELECTRODE WAS PLACED ON THE RIGHT THIGH. AFTER THE PROCEDURE A BURN WAS DISCOVERED. THE WOUND HAS BEEN DESCRIBED AS BURN OF APPROXIMATELY 2 X 2CM. THE HOSPITAL HAS REPORTED THE DISPERSIVE ELECTRODE HAS ADHERED "APPROPRIATELY". THE GENERATOR OUTPUT HAS BEEN DESCRIBED AS CUT 30, COAG 30, BLEND 1. THE WOUND HAS BEEN TREATED WITH SILVADENE CREAM. NO FURTHER INFORMATION ON THE SKIN PREPARATION, THE PATIENT INJURY, ITS PRECISE LOCATION AND THE ORIENTATION OF THE ELECTRODE ON THE PATIENT HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829167 MEGADYNE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RSW271A30 40331-0743

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other