BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLS MARTIN

    MDR report key: 6536565 · Received May 2, 2017

    Report

    Report Number
    8020045-2017-00014
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    May 17, 2017
    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

    AS NEITHER A LOT NUMBER NOR THE INVOLVED PRODUCT HAVE BEEN MADE AVAILABLE TO US, NO TESTS COULD BE PERFORMED. IT IS YET UNKNOWN WHETHER THE SKIN REACTION OCCURRED UNDERNEATH THE ELECTRODE'S FOAM TAPE OR UNDERNEATH IT'S GEL. IT IS ALSO UNCLEAR WHETHER THE SKIN REACTION CONSTITUTES AN INJURY AND WHETHER IT HAD TO BE TREATED. IT WAS NOT POSSIBLE TO RECEIVE THIS INFORMATION DESPITE REPEATED REQUESTS. WE WILL CONTINUE TO REQUEST FURTHER INFORMATION AND WILL PROVIDE ANY FINDINGS IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER NOR THE INVOLVED PRODUCT HAVE BEEN MADE AVAILABLE TO US, NO TESTS COULD BE PERFORMED. AFTER SEVERAL REQUESTS FOR MORE DETAILS OUR CUSTOMER INFORMED US: "WE HAVE REPEATEDLY MENTIONED THE URGENCY TO THE CUSTOMER. UP TO NOW WE HAVE UNFORTUNATELY NO FEEDBACK. ACCORDING TO THE CURRENT STATE, WE DO NOT EXPECT A FURTHER FEEDBACK." IT IS YET UNKNOWN WHETHER THE SKIN REACTION OCCURRED UNDERNEATH THE ELECTRODE'S FOAM TAPE OR UNDERNEATH IT'S GEL. IT IS ALSO UNCLEAR WHETHER THE SKIN REACTION CONSTITUTES AN INJURY AND WHETHER IT HAD TO BE TREATED. IT WAS NOT POSSIBLE TO RECEIVE THIS INFORMATION DESPITE REPEATED REQUESTS. WE WILL CLOSE THE INVESTIGATION. INVOLVED DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON APRIL 05TH WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A SKINTACT DISPERSIVE ELECTRODE, MODEL KLS 80-344-09-04, AND AN ESU GENERATOR, MODEL UNKNOWN, IN (B)(6) HOSPITAL IN (B)(6). THE REPORTER INITIALLY STATED: "ONE PATIENT IN (B)(6) MAY HAVE DEVELOPED AN ALLERGIC REACTIONS". NO FURTHER INFORMATION WAS PROVIDED ABOUT THE INJURY AND WHETHER IT HAD TO BE TREATED OR NOT.

    Description of Event or Problem · 1

    ON (B)(6) WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A SKINTACT DISPERSIVE ELECTRODE, MODEL KLS 80-344-09-04, AND AN ESU GENERATOR, MODEL UNKNOWN, IN (B)(6). THE REPORTER INITIALLY STATED: "ONE PATIENT IN (B)(6) MAY HAVE DEVELOPED AN ALLERGIC REACTIONS". NO FURTHER INFORMATION WAS PROVIDED ABOUT THE INJURY AND WHETHER IT HAD TO BE TREATED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318812 KLS MARTIN ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS212 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other