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

Model Number	T-601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Irritation (1941); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples of the concerned lot/batch of model sbt601 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.No information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect and details of the use was provided.We have requested further information.We will relay any further information in a follow up report.
Event or Problem Description
On july 28th, 2020, we have been informed about 9 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 9 reports covering a period from (b)(6).No medical intervention was necessary for 8 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepared using water and soap before applying the ecg electrodes.The patient experienced the "redness, itching, rash, blisters, welt, burning sensation on skin, peeling skin, burnt skin, bleeding, open sores." it was also reported that the patient stopped the study after 5 days.It was stated that a medical intervention was needed treat the injury but no details were given.No further information was provided.
Additional Manufacturer Narrative
Retained samples of the concerned lot/batch of model sbt601 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.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 leonhard lang." after requesting for several information on the usage and wearing durations we have been informed that: "we have spent years trying to get this provider to add additional questions to their patient complain process ( forms ) with no luck.I'm not sure there is much more i can do at this time." we therefore consider the investigation closed.
Event or Problem Description
On (b)(6) 2020, we have been informed about 9 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 9 reports covering a period from (b)(6).No medical intervention was necessary for 8 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 water and soap before applying the ecg electrodes.The patient experienced the "redness, itching, rash, blisters, welt, burning sensation on skin, peeling skin, burnt skin, bleeding, open sores." it was also reported that the patient stopped the study after 5 days.It was stated that a medical intervention was needed treat the injury but no details were given.No further information was provided.

• Brand Name: STABLE BASE
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10395106
• Report Number: 8020045-2020-00017
• Device Sequence Number: 19720809
• Product Code: DRX
• UDI-Device Identifier: 10861779000274
• UDI-Public: (01)10861779000274
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K023503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Other
• Device Expiration Date: 11/04/2022
• Device Model Number: T-601
• Device Catalogue Number: SBT601
• Device Lot Number: 191104-0157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention