BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 3251068 · Received July 18, 2013

    Report

    Report Number
    8020045-2013-00007
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 18, 2013
    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 OR SAMPLES HAVE BEEN MADE AVAILABLE TO US NO ANALYSIS COULD BE PERFORMED. AS NO FURTHER INFORMATION HAS BEEN PROVIDED TO US DESPITE OF REPEATED REQUESTS, NO CONCLUSION CAN BE DRAWN. 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) 2013 A HEART ABLATION PROCEDURE (DIAGNOSIS ATRIAL FLUTTER) WAS PERFORMED AT (B)(6) USA. AN UNKNOWN GENERATOR AND A MONITORING DISPERSIVE ELECTRODE (MODEL MEGADYNE 0855) WERE USED. THE DISPERSIVE ELECTRODE WAS PLACED ON THE BACK OF THE PATIENT. THE INJURY WAS COMPLAINED BY THE PATIENT (CONSCIOUS SEDATION) AS A BURNING WAS FELT IN THE BACK. THE PROCEDURE WAS CARRIED ON WITH A NEW GROUNDING PAD (MODEL MEGADYNE 0855) AT A DIFFERENT LOCATION. AFTER THE PROCEDURE, AN INJURY WAS SPECIFIED AS A MINOR BURN WITH A SMALL BLISTER. THE WOUND HAS BEEN TREATED WITH A TOPICAL OINTMENT. NO INFO OF THE PRECISE PLACEMENT SITE OF THE ELECTRODE, THE ORIENTATION OF THE BURN, HOW THE SKIN WAS PREPARED, THE GENERATOR MODEL, AND THE POWER SETTING USED HAV BEEN RECEIVED BY US DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335818 MEGADYNE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RSW271A30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other