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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 FS301
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
Retained samples of the same lot have been inspected visually and electrically.Mechanical tests were performed on 4 retained samples.All tested samples were found to perform within limits.No faults were detected.The involved device has not been made available to us.It was stated: "no samples/photos available." despite of repeated requests from us the initial reporter was not able to supply us with more information on the patient, the patient skin, the skin preparation, the duration of wearing, the skin injury itself, if and how the skin injury had to be treated.We have requested additional information and will relay any in a follow up report.
 
Event Description
On (b)(6) 2020 we have been informed about an incident involving ecg electrodes.A monitoring procedure was performed at an unknown hospital in (b)(6) using ecg electrodes (model skintact fs301 ) and an unknown ecg machine.The initial reporter provided the following information: "patient has being presenting frequently allergic reaction causing bruises.And in a child in a respiratory stage that require mechanical ventilation and must be monitored." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us despite of repeated requests.
 
Event Description
On may 20th, 2020 we have been informed about an incident involving ecg electrodes.A monitoring procedure was performed at an unknown hospital in brazil using ecg electrodes (model skintact fs301) and an unknown ecg machine.The initial reporter provided the following information: "patient has being presenting frequently allergic reaction causing bruises.And in a child in a respiratory stage that require mechanical ventilation and must be monitored." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us despite of repeated requests.
 
Manufacturer Narrative
Retained samples of the same lot have been inspected visually and electrically.Mechanical tests were performed on 4 retained samples.All tested samples were found to perform within limits.No faults were detected.The involved device has not been made available to us.It was stated: "no samples/photos available." despite of repeated requests from us the initial reporter was not able to supply us with more information on the patient, the patient skin, the skin preparation, the duration of wearing, the skin injury itself, if and how the skin injury had to be treated.We have requested several times for additional information but have not received any.We have been informed that "no response has been received from complainant.Based on the amount of times we've requested a return from this hospital, we believe it is very unlikely they'll ever give us any return.That happens because in brazil hospitals' administrations must obey to legislations that obligates any potential non-conformity to be reported to distributors/ manufacturers, however, there's no law forcing complainants into collaborating with investigations." as neither any further information nor the device involved have been made available we close the investigation.No conclusion can be drawn what might have caused the customer problem.
 
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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 Key10161897
MDR Text Key195371498
Report Number8020045-2020-00013
Device Sequence Number1
Product Code DRX
UDI-Device Identifier19005531001507
UDI-Public(01)19005531001507
Combination Product (y/n)N
PMA/PMN Number
K023503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/15/2022
Device Model NumberFS301
Device Lot Number190515-0319
Was Device Available for Evaluation? No
Date Manufacturer Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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