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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE
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LEONHARD LANG GMBH STABLE BASE; ECG ELECTRODE Back to Search Results
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 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 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.
 
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 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.
 
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Brand Name
STABLE BASE
Type of Device
ECG ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, 6020
AU  6020
MDR Report Key10395106
MDR Text Key202513630
Report Number8020045-2020-00017
Device Sequence Number1
Product Code DRX
UDI-Device Identifier10861779000274
UDI-Public(01)10861779000274
Combination Product (y/n)N
PMA/PMN Number
K023503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 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
Device Operator Other
Device Expiration Date11/04/2022
Device Model NumberT-601
Device Catalogue NumberSBT601
Device Lot Number191104-0157
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received07/28/2020
Supplement Dates FDA Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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