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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 FS-VM01
Device Problem Insufficient Information (3190)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
Retained samples of the concerned lot number 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 involved device respectively samples of the claimed lot number have not been made available to us to the date of this report.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) 2022, we have been informed about an incident involving ecg electrodes model fsvm01 at (b)(6).The initial report stated "a crew have recently reported an incident that has occurred due to removal of an ecg electrode causing skin damage to a patient.Although i have the lot number for this incident i have been made aware of similar incident without the recorded lot number, i am currently gathering the information so that i can pass this on to you.Lot number for this incident 220420-0383.I have passed on to the crew the relevance of safe storage of ecg electrodes, they assured me that the packaging was in date and only opened at the moment of placing the ecg electrodes." no further details have been disclosed so far.We have requested further information and we will follow up once we have received them.
 
Manufacturer Narrative
Retained samples of the concerned lot number 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 involved device respectively samples of the claimed lot number have not been made available to us to the date of this report.Despite repeated requests we have not received further information on the patient, the skin preparation, if and how the skin injury had to be treated at all.Therefore the incident is reported because it is unknown if and how the skin injury had to be treated.The incident might not constitute a reportable event.No conclusion can be drawn what might have caused the claimed incident.As no further information was made available, we consider the investigation closed.
 
Event Description
On june 14th, 2022 we have been informed about an incident involving ecg electrodes model fsvm01 at east midlands ambulance service nhs trust in the uk.The initial report stated "a crew have recently reported an incident that has occurred due to removal of an ecg electrode causing skin damage to a patient.(.) although i have the lot number for this incident i have been made aware of similar incident without the recorded lot number, i am currently gathering the information so that i can pass this on to you.Lot number for this incident (b)(4) i have passed on to the crew the relevance of safe storage of ecg electrodes, they assure me that the packaging was in date and only opened at the moment of placing the ecg electrodes." no further details have been disclosed so far.We have requested further information and we will follow up once we have received them.
 
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Brand Name
XLBLEU
Type of Device
ECG ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, 6020
AU  6020
Manufacturer (Section G)
LEONHARD LANG GMBH
archenweg 56
innsbruck, tirol 6020
AU   6020
Manufacturer Contact
bernhard ladner
archenweg 56
innsbruck, tirol 6020
AU   6020
MDR Report Key14913720
MDR Text Key295223018
Report Number8020045-2022-00021
Device Sequence Number1
Product Code DRX
UDI-Device Identifier19005531001453
UDI-Public(01)19005531001453
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K024247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/20/2024
Device Model NumberFS-VM01
Device Catalogue NumberFS-WA01C
Device Lot Number220420-0383
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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