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

Model Number W-601

Device Problem Insufficient Information (3190)

Patient Problems Peeling (1999); Rash (2033); Skin Burning Sensation (4540)

Event Date 06/25/2023

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot of model sbw601 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 "i do not have any additional information of any kind".As no further information was available we therefore consider the investigation and the report closed.

Event Description

On july 17th, 2023, we have been informed about 29 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 29 reports covering a period from may 05th - june 26th.No medical intervention was necessary for 28 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, soap and water before applying the ecg electrodes.The patient experienced "redness, itching, rash, welt, burning sensation on skin, peeling skin".The ecg electrodes have been removed "while bathing peeled, self detachment".It was stated that a medical intervention with anti biotic cream was used to treat the injury and that "the patient decided to stop the study after approximately 14 days of wear due to skin irritation".No further information was provided.

• Brand Name: STABLE BASE
• 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: 17440921
• MDR Text Key: 320204978
• Report Number: 8020045-2023-00023
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20861779000288
• UDI-Public: (01)20861779000288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: W-601
• Device Catalogue Number: SBW601
• Device Lot Number: 220713-0152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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