BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 23777674 · Received December 11, 2025

    Report

    Report Number
    8020045-2025-00029
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    January 19, 2026
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    29005531505197
    PMA / PMN Number
    142803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220516-4306) HAVE BEEN INSPECTED VISUALLY. ALL SAMPLES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED THE INVOLVED SAMPLE FOR INVESTIGATION OF THE ROOT CAUSE FOR THE COMPROMIZED PACKAGING. ON JANUARY 07TH, 2026 WE RECEIVED THE CLAIMED CUSTOMER SAMPLE FOR INVESTIGATION. REVIEWING THE CUSTOMER SAMPLE POUCH IT SHOWED VISIBLE AN UNSEALED AREA OVER A LENGTH OF APPROXIMATELY 8CM IN THE POUCH SEALING AT THE TOP OF THE POUCH. FURTHER INVESTIGATING IT WAS VISIBLE THAT THE TRANSPARENT AND PROTECTIVE PE FOIL LINER WAS SEALED IN. ON THE TRANSPARENT AND PROTECTIVE PE FOIL LINER SEALING MARKS ARE CLEARLY VISIBLE. THIS TRANSPARENT AND PROTECTIVE PE FOIL LINER IS INSERTED INTO THE POUCH TO PROTECT THE ELECTRODES FROM DAMAGE CAUSED BY THE PLUG OR THE CABLE ITSELF, AS THE TRANSPARENT AND PROTECTIVE PE FOIL LINER DIVIDE UP THE PRESSURE FROM SHARP CORNERS OVER A LARGER AREA ON THE ENTIRE PACKAGED ELECTRODES. WE THEREFORE HAVE EXAMINED THE ASSEMBLY AND TESTING EQUIPMENT IN THE CONCERNED PRODUCTION LINE. THE FULLY ASSEMBLED ELECTRODE SET IS PLACED IN THE POUCH MANUALLY WITH A TRANSPARENT AND PROTECTIVE PE FOIL LINER (THE LINER IS PARTIALLY PRINTED). THE ELECTRODE POUCHES THAT ARE STILL OPEN ARE THEN PLACED IN A SHORT TERM BUFFER CONTAINER. AFTER SEALING THE POUCHES, EVERY POUCH IS THEN CHECKED IN A SEPARATE STEP IN THE ASSEMBLY LINE (ACCEPTANCE CRITERIA: NO POUCH MAY SHOW ANY DAMAGE OR CONTAMINATION). AFTER CHECKING, THE FINISHED SETS ARE PACKED AFTERWARD MANUALLY IN BOXES FOR 10PCS. WE THEREFORE ASSUME THAT THE TRANSPARENT AND PROTECTIVE PE FOIL LINER WAS NOT VISUALLY DETECTED DURING THE INSPECTION. AS A CORRECTIVE ACTION WE WILL IMPROVE THE PROTECTIVE FOIL LINER TO BECOME FULLY VISIBLE. WE ASSUME THIS TO BE A SINGLE ERROR AND CONSIDER THE INVESTIGATION AND THE REPORT TO BE CLOSED. NO FURTHER CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER (220516-4306) HAVE BEEN INSPECTED VISUALLY. ALL SAMPLES WERE WITHIN LIMITS; NO FAILURE COULD BE DETECTED. WE HAVE REQUESTED THE INVOLVED SAMPLE FOR INVESTIGATION OF THE ROOT CAUSE FOR THE COMPROMIZED PACKAGING. CURRENTLY THE INVOLVED SAMPLE HAS NOT BEEN MADE AVAILABLE TO US BY THE DATE OF THIS REPORT. WE THEREFORE WILL RELAY ANY FURTHER INVESTIGATION RESULT IN A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    ON NOVEMBER 17TH, 2025, WE HAVE BEEN INFORMED BY OUR CUSTOMER COMEN ABOUT A FAILURE WITH A DEFIBRILLATION ELECTRODE SET. SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF31G HAD BEEN DETECTED AS DEFECTIVE. THE INITIAL REPORT IS STATING THAT: "THE BAG'S SEAL CAN'T BE CLOSED." WE ALSO RECEIVED ONE PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE IT IS VISIBLE A DEFECT IN THE POUCH SEALING AT THE TOP OF THE POUCH. ON JANUARY 07TH, 2026 WE HAVE RECEIVED THE CONCEREND CUSTOMER SAMPLE A FURTHER ROOT CAUSE ANALYSES . NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Description of Event or Problem · 0

    ON NOVEMBER 17TH, 2025, WE HAVE BEEN INFORMED BY OUR CUSTOMER (B)(6) ABOUT A FAILURE WITH A DEFIBRILLATION ELECTRODE SET. SKINTACT DEFIBRILLATION ELECTRODES OUR MODEL DF31G HAD BEEN DETECTED AS DEFECTIVE. THE INITIAL REPORT IS STATING THAT: "THE BAG'S SEAL CAN'T BE CLOSED." WE ALSO RECEIVED ONE PICTURE SHOWING THE CLAIMED DEFECT. REVIEWING THE CUSTOMER PICTURE, IT IS VISIBLE A DEFECT IN THE POUCH SEALING AT THE TOP OF THE POUCH. FOR A FURTHER ROOT CAUSE ANALYSES, WE HAVE REQUESTED THE CONCERNED CUSTOMER POUCH. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526449 SKINTACT MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF31G 250707-4042 29005531505197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other