MAUDE Adverse Event Report: LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE

Model Number	T-601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Peeling (1999); Rash (2033)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, we have been informed about 39 incidents with ecg electrodes.Monitoring ecg electrodes (model sbw601 and sbt601) had been used with bodyguardian mini+ and bodyguardian one devices.The initial reporter has attached for each patient an incident summary.In total, there were (b)(4) reports covering a period from (b)(6) 2024 - (b)(6) 2025.No medical intervention was necessary for 38 incidents.For one incident a medical intervention was needed to treat the injury.The reportable event has happened on (b)(6) 2025.It was disclosed that the patient's skin was prepared using soap and water before applying the ecg electrodes.The patient experienced "redness, itching, rash, open sores ".It was reported that the ecg study lasted for 13 days and the ecg electrodes have been changed daily.The ecg electrodes removal has been disclosed as "gently rolled dry".The initial report also specifies the information: "placed by existing irritation? no".It was also stated that a medical intervention was necessary but no further information was provided how it was treated afterwards.No further information was provided.
Additional Manufacturer Narrative
Retained samples of the concerned lot of model sbt601 have been inspected visually.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 further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and how the medical intervention was done.We will provide a follow up report once any further information is available.
Additional Manufacturer Narrative
Retained samples of the concerned lot of model sbt601 have been inspected visually.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 further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and have been informed that "i would not expect any more information about this complaint." as no further information was made available we therefore consider the investigation and the report closed.
Event or Problem Description
On may 06th, 2025, we have been informed about 39 incidents with ecg electrodes.Monitoring ecg electrodes (model sbw601 and sbt601) had been used with bodyguardian mini+ and bodyguardian one devices.The initial reporter has attached for each patient an incident summary.In total, there were 39 reports covering a period from october 21st, 2024 to march 16th, 2025.No medical intervention was necessary for 38 incidents.For one incident a medical intervention was needed to treat the injury.The reportable event has happened on february 05th, 2025.It was disclosed that the patient's skin was prepared using soap and water before applying the ecg electrodes.The patient experienced "redness, itching, rash, open sores ".It was reported that the ecg study lasted for 13 days and the ecg electrodes have been changed daily.The ecg electrodes removal has been disclosed as "gently rolled dry".The initial report also specifies the information: "placed by existing irritation? no".It was also stated that a medical intervention was necessary but no further information was provided how it was treated afterwards.No further information was provided.

• Brand Name: STABLE BASE
• 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: thomas recheis ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 22121591
• Report Number: 8020045-2025-00009
• Device Sequence Number: 4171368
• Product Code: DRX
• UDI-Device Identifier: 20861779000288
• UDI-Public: (01)20861779000288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: Other
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 241002-0222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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: Unknown