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 08/09/2023

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 been informed that "there is no additional information provided besides these submissions".Therefore no 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 have been received.We don't know for sure, but we assume from the statement that the ecg electrodes have been removed "abruptly peeled dry" in the initial report the ifu has not been followed.The ifu explicitly states "after use, carefully remove the electrode using one hand whilst supporting the skin beneath it with the other.Ripping off the electrode or peeling it off quickly may damage the skin." we assume the user has contributed or caused the event.As no further information was available we therefore consider the investigation and the report closed.

Event Description

On (b)(6), 2023, we have been informed about 25 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 25 reports covering a period from (b)(6).No medical intervention was necessary for 24 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepaed using soap and water before applying the ecg electrodes.The patient experienced "redness, itching, rash, welt, burning sensation on skin, peeling skin".It was reported that the ecg electrodes have been removed "abruptly peeled dry".It was stated that a medical intervention with hydrcortizone cream was used to treat the injury.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: 18090975
• MDR Text Key: 327590897
• Report Number: 8020045-2023-00025
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 221116-0155
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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