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

Model Number T-601

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the model sbt601 lot number: 200228-0257, 200204-0253, 200227-0256, 200225-0255, 191029-0155, 200204-0253, 200303-0258 and model sbw601 lotnumber: 200220-0253, 200219-0252, 200211-0257, 200217-0251, 200219-0252, 200121-0155, 200213-0258 have been inspected visually.Mechanical tests were performed on 3 retained samples each.All tested samples were found to perform within limits.No faults could be detected.No information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use was provided.We have requested further information and have been informed by the initial reported that per hippa regulations much of the information leonhard lang requests can't be reported.We therefore consider the investigation closed.

Event Description

On (b)(6) 2021, we have been informed about 32 incidents with ecg electrodes.Monitoring ecg electrodes (model sbt601 and sbw601) had been used with bodyguardian one and bodyguardian verite one devices.The initial reporter has attached for each patient an incident summary.In total, there were 32 reports covering a period from (b)(6) 2020.No medical intervention was necessary for 29 incidents.For 3 incidents a medical intervention was needed to treat the injury but no further details were given.Before applying the ecg electrodes, the skin of the patients requiring intervention was prepared using water and soap.The 3 patients developed itching, burning sensation on skin, burnt skin, redness, welt, peeling skin and bleeding.One patient report provided the information that the patient paused the study to wait for the skin irritation to heal.A medical intervention was necessary.All other 29 patients were prepared with different methods using water and soap, alcohol, alcohol wipes or saline wipes before applying the ecg electrodes.The patients were experiencing "redness, itching, rash, blisters, welt, burning sensation on skin, peeling skin, burnt skin, bleeding, open sores." 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: 11479879
• MDR Text Key: 244206292
• Report Number: 8020045-2021-00009
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10861779000274
• UDI-Public: (01)10861779000274
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 200228-0257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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