BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 24661002 · Received March 23, 2026

    Report

    Report Number
    8020045-2026-00009
    Event Type
    Injury
    Date Received
    March 23, 2026
    Report Date
    March 23, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    19005531502342
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON THREE RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. THE INITIAL REPORTER INFORMED US THAT THE INVOLVED DEVICE IS NOT AVAILABLE FOR AN INVESTIGATION. WE HAVE REQUESTED ADDITIONAL INFORMATION AND NONE HAVE BEEN RECEIVED DESPITE REQUESTS. THE INITIAL REPORTER HAS INFORMED US: "UNFORTUNATELY, THE INFORMATION PROVIDED IS LIMITED AND WE HAVE NO WAY OF KNOWING OR CONTACTING THE PERSON WHO REPORTED THE COMPLAINT." WE THEREFORE WILL CLOSE OUT THE INVESTIGATION AND THE REPORT. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED INCIDENT.

    Description of Event or Problem · 0

    ON FEBRUARY 26TH, 2026, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED AT AN UNKNOWN USER SITE IN (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL SKINTACT RO21) AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED "WE HAVE RECENTLY RECEIVED A TECHNICAL COMPLAINT FROM MINISTRY OF HEALTH (ANVISA) AGAINST ONE OF YOUR PRODUCTS. NOTIVISA#: 2026.02.003920 REMINDER: NOTIVISA IS A PLATFORM BY (B)(6) HEALTH THAT ALLOW CUSTOMERS TO REPORT POSSIBLE QUALITY-DEVIATIONS ANONYMOUSLY. IN SUCH CASES WE ARE NOT ABLE TO REQUEST ADDITIONAL INFORMATION, PHOTOS, OR SAMPLES TO CUSTOMERS. COMPLAINT DESCRIPTION: "THE ELECTROCAUTERY PLATE CAUSED A SKIN INJURY TO THE PATIENT AFTER ITS USE." PRODUCT: SKINTACT NEUTRAL ELECTRODE RO21, LOT: 240221-0803, CODE: RO21 (OR R021), EXPIRY DATE: 02/2027." NO INFORMATION ABOUT THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENT, HOW THE SKIN WAS PREPARED, IF AND HOW THE INJURY WAS TREATED AFTERWARDS HAVE BEEN DISCLOSED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724685 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RO21 240221-0803 19005531502342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other