MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number TVO01

Device Problem Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot of model tvo01 have been inspected visually.All inspected samples were found to perform within limits.We also have reviewed the production history records for the concerned lot number.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.We have requested customer samples but none have been received so far.The user was specifying in the filled in questionnaire that the patient skin was prepared with 3m cavilon.Reviewing 3m cavilon we have detected [source: (b)(6)].A brochure specifying that: [translated from german to english language] "irritation-free skin protection film is a unique alcohol-free liquid that is applied to dry, clean skin and dries to a breathable and transparent film in approximately 30 seconds.Irritant-free solvents (esther) keep cavilon¿ irritant-free skin protection film in a volatile, homogeneous solution".Further on this brochure states [translated from german to english language] "contraindications (.) underneath ecg electrodes".The ifu also explicitly states that "do not use solvent-based liquids to clean the skin because such agents can lead to skin reactions when trapped under the electrode." esther is such a solvent based liquid as specified in the 3m cavilon brochure.We therefore consider the user has contributed to or caused the event.We therefore close the investigation.

Event Description

On (b)(6), 2023, we have been informed about two incident with ecg electrodes at a hospital, in luxembourg.Skintact electrodes model t-vo01, lot number 230517-0246 have been used.The complainant reported "i have received a complaint for electrodes skintact tvo01.Two patients have been burn after those electrodes remain on their skin during a 24h holter monitoring.Patients do not have any known allergy and as per the doctor it could be chemical burn." the initial report contained also a picture showing the patient injury.The resolution of the picture is low but it is visible that 4 ecg electrodes had been applied to the patient and underneath two of the 4 attached ecg electrodes a skin injury had happened visible on the picture.On (b)(6), 2023 we have received a filled questionnaire for both involved patients and pictures with a high resolution showing the injuries.It was stated that a 24 hours holter was performed on both patients.An unknown monitor and 7 skintact ecg electrodes model tvo01 have been used per patient.Patient a: was described as 11 year old male patient normal body type, caucasian and normal skin.The general state of the patient was normal.The skin preparation was described as not shaven but cleaned, not disinfected, cavilon as ointment was applied and dried.7 ecg electrodes have been placed on the patient torso.After the procedure "when the electrodes were taken off" underneath 5 of the 7 applied ecg electrodes, in the centre of the ecg electrodes skin injuries have been detected.It was described that the injuries have occurred "underneath the metal part / green gel" and the size was described as "spot of exact form of the metal part / green gel".Reviewing the pictures showing the skin injuries we can see circular open sores limited to the gel area.In an later e-mail it was specified that the skin injuries have been treated by "flammazine that the patient had decided to the initiative of the client".Patient b: was described as 22 year old female patient normal body type, caucasian and normal skin.The general state of the patient was normal.The skin preparation was described as not shaven but cleaned, not disinfected, cavilon as ointment was applied and dried.7 ecg electrodes have been placed on the patient torso.After the procedure "when the electrodes were taken off" underneath 5 of the 7 applied ecg electrodes, in the centre of the ecg electrodes skin injuries have been detected.It was described that the injuries have occurred "underneath the metal part / green gel" and the size was described as "spot of exact form of the metal part / green gel".Reviewing the pictures showing the skin injuries we can see circular open sores limited to the gel area.In an later e-mail it was specified that the skin injuries have been treated by "dermatologic with flammazine cream 1 application per day during 3 weeks / lalusept cream 1 application per day during 3 weeks / kelocote gel to start after the skin had recover completely 2 application per day during 3 month ".No further details have been disclosed.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 17983229
• MDR Text Key: 326236134
• Report Number: 8020045-2023-00024
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TVO01
• Device Lot Number: 230517-0246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Race: White