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

Model Number T-601

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot/batch (191029-0155, 191104-0157 and 200130-0259) of model sbt601 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 several times but none was made available.The initial reporter was specifying "we continue to encourage the customer to provide this information.However we can't force them to do so.Our customer is a very large healthcare provider in the united states and they have a general system for patient complaints.They will not develop a special tracking system and process for (b)(6)." we therefore consider the investigation closed.

Event Description

On (b)(6) 2020, we have been informed about 14 incidents with ecg electrodes.Monitoring ecg electrodes (model sbt601) had been used with body guardian one and body guardian verite one devices.The initial reporter has attached for each patient an incident summary.In total, there were 14 reports covering a period from july 02 to august 17.No medical intervention was necessary for 13 incidents.For 1 incident a medical intervention was needed to treat the injury but no further details were given.Before applying the ecg electrodes, the skin of the patient requiring intervention was prepared using water and soap.He developed open sores and bleeding.The patient paused the study to wait for the skin to heal.A medical intervention was necessary.All other 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 the "redness, itching, rash, blisters, welt, burning sensation on skin, peeling skin, burnt skin, bleeding, open sores." no further information was provided.

Event Description

On october 19th, 2020, we have been informed about 14 incidents with ecg electrodes.Monitoring ecg electrodes (model sbt601) 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 14 reports covering a period from (b)(6).No medical intervention was necessary for 13 incidents.For 1 incident a medical intervention was needed to treat the injury but no further details were given.Before applying the ecg electrodes, the skin of the patient requiring intervention was prepared using water and soap.He developed open sores and bleeding.The patient paused the study to wait for the skin to heal.A medical intervention was necessary.All other 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 the "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 concerned lot/batch (191029-0155, 191104-0157 and 200130-0259) of model sbt601 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 several times but none was made available.The initial reporter stated that no further information has been made available despite repeated requests.We therefore consider the investigation closed.

• Brand Name: STABLE BASE
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10850224
• MDR Text Key: 216649293
• Report Number: 8020045-2020-00028
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10861779000274
• UDI-Public: (01)10861779000274
• 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,Followup
• Report Date: 02/03/2021

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: 01/30/2023
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 200130-0259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention