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

Model Number	TVO01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional 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 several times for a filled in questionaire and customer samples but none have been received.On may 08th, 2024 we have received a partially filled in qustionaire.The user was specifying in the filled in questionnaire that the patient skin was prepared with "ambu skin prep pad" and desinfected with "clinell 2% chlorhexidine in 70% alcohol skin wipe." the ifu 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." 2% chlorhexidine in 70% alcohol is such a solvent based liquid.We therefore consider the user has caused or contributed to the event.We therefore close the investigation.
Event or Problem Description
On april 26th, 2024, we have been informed about an incident with ecg electrodes.Monitoring ecg electrodes (model tvo01) had been used at mid yorkshire nhs teaching trust.The initial reporter informed leonhard lang about a patient incident.It was stated: "i have a patient incident where the electrodes have actually burnt the patients skin i do have photographs." on may 08th, 2024 we have received a picture showing the skin injury and a partially filled in questionaire.A "24 hour ambulatory ecg" monitoring was performed.The patient skin was described as normal.The medical history was described as "no known allergies - patient was asked at the time of fitting ".3 ecg electrode have been applied on the patients chest.The skin preparation was described as cleaned with "ambu skin prep pad", not shaven, disinfected with "clinell 2% chlorhexidine in 70% alcohol skin wipe", no ointment has been used and dried with paper towel.Hours after the treatment the patient noticed at home in the "right upper chest area burning and sore, blisters appeared".It was described "patient was sleeping - woke up with a burning sensation around 3 am where the upper sticker was placed".No information was provided if and how the injury has to be treated afterwards.Reviewing the provided customer picture a circular skin injury has happened at the outer foam edge of the ecg electrode.It was also stated: "imagine the patient's injury (16/04/2024/).Picture taken on the (b)(6) 2024 when the patient returned for advice." no further details have been disclosed so far.

• Brand Name: SKINTACT
• Common Device Name: 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: 19329446
• Report Number: 8020045-2024-00012
• Device Sequence Number: 6942407
• Product Code: DRX
• UDI-Device Identifier: 19005531505480
• UDI-Public: (01)19005531505480
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2025
• Device Model Number: TVO01
• Device Lot Number: 230926-0243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female