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	Peeling (1999); Rash (2033); Skin Burning Sensation (4540)
Type of Reportable Event	Serious Injury
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 "there is no additional information provided besides these submissions".As no further information was available we therefore consider the investigation and the report closed.
Event or Problem Description
On february 20th, 2024, we have been informed about 23 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 23 reports covering a period from august 15th - november 03rd.No medical intervention was necessary for 22 incidents.For one incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepared using saline wipes, soap and water before applying the ecg electrodes.The patient experienced "redness, itching, rash, blisters, burning sensation on skin, peeling skin, burnt skin, bleeding, open sores".It was reported that the ecg electrodes peeled when bathing.It was stated that a medical intervention with hydrocortisone cream usp 2.5 was used to treat the injury.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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 18892570
• Report Number: 8020045-2024-00004
• Device Sequence Number: 15329707
• 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
• Report Date (Section B): 03/13/2024

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: Other
• Device Expiration Date: 01/27/2026
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 230127-0156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2023
• 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: Unknown