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 Code	Blister (4537)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples of the concerened lot batch 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 for 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 "no additional information of any kind" was available.We therefore consider the investigation and the report closed.
Event or Problem Description
On (b)(6) 2023 , we have been informed about 26 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 26 reports covering a period from (b)(6) thru (b)(6).No medical intervention was necessary for 25 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepered using saline wipes before applying the ecg electrodes.The patient experienced "redness, peeling skin, open sores".The ecg electrodes have been removed "gently rolled dry".It was also reported that the patient decided to pause the study and decided that they will reconnect once the reported skin irritation heals.It was stated that a medical intervention with neosporin was used to treat the injury and that the patient decided to pause the study and decided that they will reconnect once the reported skin irritation heals.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: 16858656
• Report Number: 8020045-2023-00011
• Device Sequence Number: 17858823
• 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): 05/03/2023

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: 08/16/2025
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 220816-0182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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