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  

Event Description

On october 13th, 2021, we have been informed about (b)(6) 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 (b)(6) reports covering a period from (b)(6) 2021.No medical intervention was necessary for (b)(6) incidents.For 5 incidents a medical intervention was needed to treat the injury.Before applying the ecg electrodes, the skin of the patients requiring intervention was prepared using water and soap respectively one patient saline wipe.The 5 patients developed "redness, itching, rash, blisters, burning sensation on skin, peeling skin, burnt skin, welt, bleeding, open sores".For one of these patients the report provided the information that "patient stated their skin was oozing and applied cortisone per doctor's orders.Patient stated they changed the electrodes multiple times due to speaking with us for poor skin contact." this patient was undergoing a 10 days study.Ecg electrodes were worn for 6 days and were changed within this time for 10 times.Further on it was reported that no skin irritation existed before applying the ecg electrodes to the skin.For the removal details it was stated "removal details: abruptly peeled dry".For the other four of the five patients the filled in form stated only (question: "medical intervention?): "yes.No information was provided as the to the treatment received." all other 23 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.

Manufacturer Narrative

Retained samples of the model sbt601 lot numbers 210319-0253, 210128-0154, 210127-0076, 201113-0257, 210322-0254 and of model sbw601 lot numbers 201019-0074, 201027-0251, 200923-0259, 210128-0154 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.

• Brand Name: STABLE BASE
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 12750310
• MDR Text Key: 282555591
• Report Number: 8020045-2021-00021
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 120861779000288
• UDI-Public: (01)120861779000288
• Combination Product (y/n): N
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 11/04/2021

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
• Device Operator: Other
• Device Expiration Date: 03/19/2024
• Device Model Number: T-601
• Device Catalogue Number: SBT-601
• Device Lot Number: 210319-0253
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other