BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 21749680 · Received April 2, 2025

    Report

    Report Number
    8020045-2025-00006
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 15, 2025
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    19005531505487
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED AND RETURNED CUSTOMER SAMPLES OF THE CONCERNED LOT NUMBERS 240925-0243 AND 241206-0242 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED AND RETURNED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. DESPITE THE STATEMENT: "NIL TREATMENT. IMPROVED WITH REMOVAL OF ELECTRODES AND ALLOWED SKIN TO HEAL." WE ASSUME A REPORTABLE EVENT HAS HAPPENED BASED ON THE INVESTIGATION OF THE PROVIDED CUSTOMER PICTURE. WE HAVE REQUESTED ADDITIONAL INFORMATION "HOW LONG WERE THE ELECTRODES PLACED ON THE PATIENT? WHEN THE ELECTRODES WERE REPLACED, DID THEY PUT THE NEW ONES ON THE SAME SPOT?" AND HAVE BEEN INFORMED THAT "ALL ELECTRODES ARE REPLACED ON EACH 12 HOUR SHIFT OR WHEN REQUIRED ON DIFFERENT AREAS OF THE CHEST." IT IS THEREFORE UNCLEAR WHAT HAS CAUSED OR CONTRIBUTED TO THE PATIENT INJURY. BASED ON THE PROVIDED INFORMATION NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PATIENT INJURY. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    RETAINED AND RETURNED CUSTOMER SAMPLES OF THE CONCERNED LOT NUMBERS 240925-0243 AND 241206-0242 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED AND RETURNED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON THE PATIENT, SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, DURATION OF USE AND DETAILS OF THE USE WAS PROVIDED. DESPITE THE STATEMENT: "NIL TREATMENT. IMPROVED WITH REMOVAL OF ELECTRODES AND ALLOWED SKIN TO HEAL." WE ASSUME A REPORTABLE EVENT HAS HAPPENED BASED ON THE INVESTIGATION OF THE PROVIDED CUSTOMER PICTURE. WE REPEATEDLY HAVE REQUESTED FOR FURTHER INFORMATION AND HAVE BEEN INFORMED THAT "I WILL FORWARD YOU THE FORM [QUESTIONAIRE] AS SOON AS IT'S COMPLETED BY THE CUSTOMER" WE THEREFORE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED FURTHER INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT CAVAN GENERAL HOSPITAL IN IRELAND. SKINTACT ELECTRODES MODEL TVO01 WERE USED. THE INITIAL REPORTER STATED THAT " OUR SALES REP MET THE STAFF AND WAS TOLD THAT 3 PATIENTS HAD A REACTION TO ELECTRODES AND ONE OF THEM HAD BURNS ON LEFT UPPER CHEST. (...). THIS PERSON HAD A PACEMAKER IN THIS GENERAL AREA AND THE ELECTRODES HAD BEEN CHANGED EVERY DAY. THEY HAVE STOPPED USING THEM & ONLY HAD 2 PACKETS LEFT IN ICU. (...) · LOCATION: ICU, CAVAN GENERAL HOSPITAL. · DATE: THE INCIDENTS OCCURRED ON 3 PATIENTS BETWEEN FEB 24TH- 28TH. · REPORTED BY: THE INCIDENTS WERE REPORTED BY STAFF NURSE/HCA TO CNM. · PERSONS INVOLVED: 3 PATIENTS IN ICU. · DESCRIPTION OF INCIDENT/INJURY: ON REMOVAL OF ELECTRODES NOTED, BURN TYPE SKIN INJURY RESULTING IN BLISTERS AND FORMED SCABBED AREAS. · DESCRIPTION OF TREATMENT APPLIED: NIL TREATMENT. IMPROVED WITH REMOVAL OF ELECTRODES AND ALLOWED SKIN TO HEAL." WE NATIONALLY HAVE RECEIVED ONE PICTURE SHOWING THE PATIENT INJURY. THE PICTURE IS OF POOR QUALITY AND THEREFORE MAKES IT DIFFICULT TO MAKE A PRECISE ASSESMENT. IT IS UNCLEAR WHETHER AN ALLERGIC REACTION, BLISTERS ARE A BURN OR A SEVERE SKIN REACTION HAVE OCCURED. WE HAVE REQUESTED FURTHER INFORMATION AND RECEIVED ON APRIL 10TH, 2025 A FILLED IN QUESTIONAIRE. WITHIN THE QUESTIONNAIRE IT WAS STATED THAT THE PROCEDURE WAS AT CAVAN GENERAL HOSPITAL AND A CONTINUOUS INTENSIVE CARE MONITORING WAS PERFORMED. THE USER WAS SPECIFYING THAT A HEMODYNAMIC ECG MONITORING WAS PERFORMED OVER A DURATION OF "DAYS -> WEEKS" [SIC]. A PHILIPS CARDIAC MONITOR WAS USED TO RECORD THE READINGS. THE CONCERNED FEMALE PATIENT HAS BEEN DESCRIBED AS 51 YEARS OLD AND OF 100KG+ WEIGHT. THE PATIENT WAS DESCRIBED AS OBESE AND THE SKIN AS NORMAL WITH NO ALLERGIES. THE GENERAL CONDITION OF THE PATIENT WAS DESCRIBED AS "VENTILATED - RESPIRATORY FAILURE". THE PATIENT SKIN WAS CLEANED, NOT SHAVEN, NOT DISINFECTED, BUT DRIED PRIOR ECG ELECTRODE APPLICATION. 5 ECG ELECTRODES HAD BEEN PLACED ON PATIENT'S CHEST AREA. THE USER REPORTED THAT DURING THE TREATMENT UNDERNEATH THE ADHESIVE AND THE GEL AREA "BURN TYPE SKIN INJURY CAUSING BLISTERS + SCAB AREA" HAVE BEEN DETECTED. HOWEVER, NO SKIN TREATMENT WAS NECESSARY. IT WAS REPORTED "NIL - SOME REMOVED AND SKIN CLEANED." AND "NIL MEDICAL TREATMENT REQUIRED". NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES (B)(6) HOSPITAL IN (B)(6). SKINTACT ELECTRODES MODEL TVO01 WERE USED. THE INITIAL REPORTER STATED THAT " OUR SALES REP MET THE STAFF AND WAS TOLD THAT 3 PATIENTS HAD A REACTION TO ELECTRODES AND ONE OF THEM HAD BURNS ON LEFT UPPER CHEST. THIS PERSON HAD A PACEMAKER IN THIS GENERAL AREA AND THE ELECTRODES HAD BEEN CHANGED EVERY DAY. THEY HAVE STOPPED USING THEM & ONLY HAD 2 PACKETS LEFT IN ICU. LOCATION: ICU, (B)(6) HOSPITAL. DATE: THE INCIDENTS OCCURRED ON 3 PATIENTS BETWEEN (B)(6). REPORTED BY: THE INCIDENTS WERE REPORTED BY STAFF NURSE/HCA TO CNM. PERSONS INVOLVED: 3 PATIENTS IN ICU. DESCRIPTION OF INCIDENT/INJURY: ON REMOVAL OF ELECTRODES NOTED, BURN TYPE SKIN INJURY RESULTING IN BLISTERS AND FORMED SCABBED AREAS. DESCRIPTION OF TREATMENT APPLIED: NIL TREATMENT. IMPROVED WITH REMOVAL OF ELECTRODES AND ALLOWED SKIN TO HEAL." WE ADDIOTNALLY HAVE RECEIVED ONE PICTURE SHOWING THE PATIENT INJURY. THE PICTURE IS OF POOR QUALITY AND THEREFORE MAKES IT DIFFICULT TO MAKE A PRECISE ASSESMENT. IT IS UNCLEAR WHETHER AN ALLERGIC REACTION, BLISTERS ARE A BURN OR A SEVERE SKIN REACTION HAVE OCCURED. WE HAVE REQUESTED FURTHER INFORMATION FOR FURTHER INVESTIGATION. NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUEST SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613746 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH TVO-01 240925-0243 19005531505487

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other