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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEONHARD LANG GMBH XLBLEU; ECG ELECTRODE
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LEONHARD LANG GMBH XLBLEU; ECG ELECTRODE Back to Search Results
Model Number FSVM01
Device Problem Insufficient Information (3190)
Patient Problem Skin Tears (2516)
Event Type  Injury  
Manufacturer Narrative
Retained samples of the same lot have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The initial reporter stated that samples of the same lot are available from the user for further investigation.We have asked to be sent customer samples of the same lot.We have requested further information on the patient, the skin preparation, if and how the skin injury had to be treated and will provide a follow up report upon receipt.
 
Event Description
On (b)(6) 2020, we have been informed about an incident with ecg electrodes at (b)(6) healthcare nhs foundation trust (b)(6) service, in (b)(6).Xlbleu electrodes model fs-wa01c were used.The complainant reported "we seem to be receiving complaints about a particular batch of electrodes from the crews saying they are too sticky to the point they are tearing the patients skin when being removed.The crews have said they have compared them to other batches and they appear to be more sticky." we have requested further information on each involved patient, the skin preparation, if and how the skin injuries had to be treated.
 
Manufacturer Narrative
Retained samples of the same lot have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The initial reporter stated that samples of the same lot were available from the user for further investigation.However, the customer returned only samples from different lot numbers, 200131-0204 and 200424-0206.The samples were inspected visually.Mechanical tests were performed on 3 samples each returned lot number.All tested samples were found to perform within limits.No faults could be detected.Comparing the adhesive force of the claimed electrode type with other electrode types using the same adhesive foam has shown that there are no differences noticeable in the adhesion force.Furthermore we have examined the supplier´s cocs of the concerned foam.The documents have shown that the specified adhesion force values have not changed during the last year.We have requested several times for further information on the patient, the skin preparation, if and how the skin injury had to be treated.The initial reporter has confirmed that no further information is available.The incident has been reported because it is unknown if and how the skin injury had to be treated afterwards.The incident might not constitute a reportable event.As no further information was made available despite of repeated requests, no conclusion can be drawn what might have caused the incidents.We therefore close the investigation.
 
Event Description
On july 21st, 2020, we have been informed about an incident with ecg electrodes at (b)(6), in (b)(6).Xlbleu electrodes model fs-wa01c were used.The complainant reported "we seem to be receiving complaints about a particular batch of electrodes from the crews saying they are too sticky to the point they are tearing the patients skin when being removed.The crews have said they have compared them to other batches and they appear to be more sticky." we have requested further information on each involved patient, the skin preparation, if and how the skin injuries had to be treated.
 
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Brand Name
XLBLEU
Type of Device
ECG ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, 6020
AU  6020
MDR Report Key10395103
MDR Text Key202528450
Report Number8020045-2020-00016
Device Sequence Number1
Product Code DRX
UDI-Device Identifier19005531001456
UDI-Public(01)19005531001456
Combination Product (y/n)N
PMA/PMN Number
K024247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 11/10/2020
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 Health Professional
Device Expiration Date04/21/2022
Device Model NumberFSVM01
Device Catalogue NumberFS-WA01C
Device Lot Number200421-0204
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received07/21/2020
Supplement Dates FDA Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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