BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASMUTH

    MDR report key: 4959448 · Received July 29, 2015

    Report

    Report Number
    8020045-2015-00050
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE INVOLVED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. THE MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. THE SKIN COMPATIBILITY WAS ALSO TESTED FOR 4 HOURS ON A TEST PERSON. NO FAULTS COULD BE DETECTED. AFTER REPEATED REQUESTS FOR FURTHER INFORMATION WE HAVE NOT RECEIVED ANY. THE DISTRIBUTOR HAS EXPLICITLY COMMUNICATED THE UNWILLINGNESS OF THE USER AND THE PATIENT TO PROVIDE ANY FURTHER INFORMATION FOR THIS INCIDENT. DUE TO THE LACK OF INFORMATION, WE ARE UNABLE TO ESTABLISH, IF THIS INJURY CONSTITUTES A REPORTABLE INCIDENT. AS WE CANNOT EXPECT ANY FURTHER INFORMATION, WE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2015, WE HAVE BEEN INFORMED THAT A PATIENT WAS INJURED DURING A PROCEDURE. PHOTOS OF THE INJURY WERE TAKEN RIGHT AFTER THE PROCEDURE AND SENT TO US. ON THESE IMAGES A CIRCLE OF REDNESS (POSSIBLY AN ALLERGIC REACTION) APPEARS WHERE THE ELECTRODE'S ADHESIVE TAPE AND THE EDGE OF THE CONDUCTIVE GEL HAD ADHERED TO THE SKIN. IT IS ALSO VISIBLE ON THE PHOTOS THAT THE ELECTRODE WAS PLACED ON THE LEFT THIGH OF THE PATIENT. NO INFORMATION ABOUT THE PATIENT, THE NATURE AND DURATION OF THE PROCEDURE, THE GENERATOR MODEL, THE POWER SETTINGS, HOW THE SKIN WAS PREPARED, THE ORIENTATION OF THE ELECTRODE AND IF AND HOW THE INJURY WAS TREATED HAVE BEEN DISCLOSED TO US DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492656 ASMUTH ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH WR21 50226-0805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other