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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE
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LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE Back to Search Results
Model Number PD50-SFC
Device Problem Insufficient Information (3190)
Patient Problems Hyperemia (1904); Superficial (First Degree) Burn (2685)
Event Date 11/29/2020
Event Type  Injury  
Manufacturer Narrative
Retained samples of the concerned lot have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.The adhesive performance was also tested for 4 hours on a test person.No faults could be detected.The ifu explicitly states that extra care has to be taken upon removal "when skin is overly delicate" and that "tugging, pulling or rapid removal may cause skin trauma".It is unclear, how exactly the electrode has been removed from the premature baby and whether the ifu has been followed or not.No further conclusion can be drawn.
 
Event Description
On (b)(6), we have been informed by id&co s.R.L.About an incident using ecg electrodes at (b)(6).The ecg electrodes (pd50-sfc) were applied to a premature baby.The body type was described as slim and skin type as normal no hair.According to the questionnaire the skin was not cleaned, not shaven, not disinfected but dried were performed.Three electrodes had been applied to the baby and underneath the adhesive area and gel contact area of one electrode applied on the stomach of the baby an injury was discovered.It was described that during the treatment the patient showed hyperemia in abdominal area around the ecg electrode, after the treatment the customer discover an hyperemic area with vesicle partially intact, superficial burn.The duration of the procedure was specified as "ten minutes".The injury was described in size 1,5 x 2cm.The injury care was described as "treatment with connective and application of gauze".We additionally received two photos showing the patients injury assuming one taken at the time the injury occured.The second picture is showing the same part of the body completely healed.
 
Manufacturer Narrative
Retained samples of the concerned lot have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.The adhesive performance was also tested for 4 hours on a test person.No faults could be detected.After several requests we have received customer samples of the same lot for further investigation.The returned customer samples of the concerned lot have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.The ifu explicitly states that extra care has to be taken upon removal "when skin is overly delicate" and that "tugging, pulling or rapid removal may cause skin trauma".It is unclear, how exactly the electrode has been removed from the premature baby and whether the ifu has been followed or not.No further conclusion can be drawn.
 
Event Description
On december 10th, we have been informed by (b)(6) about an incident using ecg electrodes at (b)(6) italy.The ecg electrodes (pd50-sfc) were applied to a premature baby.The body type was described as slim and skin type as normal no hair.According to the questionnaire the skin was not cleaned, not shaven, not disinfected but dried were performed.Three electrodes had been applied to the baby and underneath the adhesive area and gel contact area of one electrode applied on the stomach of the baby an injury was discovered.It was described that during the treatment the patient showed hyperemia in abdominal area around the ecg electrode, after the treatment the customer discover an hyperemic area with vesicle partially intact, superficial burn.The duration of the procedure was specified as "ten minutes".The injury was described in size 1,5 x 2cm.The injury care was described as "treatment with connective and application of gauze".We additionally received two photos showing the patients injury assuming one taken at the time the injury occured.The second picture is showing the same part of the body completely healed.
 
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Brand Name
SKINTACT
Type of Device
ECG ELECTRODE
Manufacturer (Section D)
LEONHARD LANG GMBH
archenweg 56
innsbruck, 6020
AU  6020
MDR Report Key11044313
MDR Text Key222623524
Report Number8020045-2020-00032
Device Sequence Number1
Product Code DRX
UDI-Device Identifier19005531000418
UDI-Public(01)19005531000418
Combination Product (y/n)N
PMA/PMN Number
K080106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
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 Health Professional
Device Expiration Date04/26/2023
Device Model NumberPD50-SFC
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age7 DA
Patient Weight1
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