MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS25A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually, electrically and thermally.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 for an investigation.Based on the information made available to us, no conclusion can be drawn as to what might have caused the irritation.We are requesting additional information.Upon receiving this we will provide a follow-up report.
Event or Problem Description
On (b)(6) 2018 we have been informed about an incident involving a dispersive electrode.An unknown electrosurgical procedure was performed at (b)(6) hospital in (b)(6).A monitoring dispersive electrode (model skintact rs25a30) and an unknown generator were used.The initial report claimed that the "product cause irritation in a patient when practice the procedure".It is unclear whether the irritation were located underneath the electrode respectively underneath the gel or the surrounding foam are and of what severity the irritation was.No information about the nature of the procedure, the generator model, the power settings, the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us despite of repeated requests.
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually, electrically and thermally.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, no conclusion can be drawn as to what might have caused the irritation.We have requested additional information several times.Particularly if there are any photos of the irritation, if and how the irritation was treated after this incident, if the irritation was found right after the surgery, how the skin preparation was performed.Our customer informed us on september 11th:"about the mentioned event, we have not more information from the doctors, the only information we had from a nursery was that the patient only present some irritation on the leg.Unfortunately the doctor did not give us more information." we therefore consider the investigation closed.
Event or Problem Description
On (b)(6)2018 we have been informed about an incident involving a dispersive electrode.An unknown electrosurgical procedure was performed at roosevelt hospital in guatemala city.A monitoring electrode (model skintact rs25a30) and an unknown generator were used.The initial report claimed that the "product cause irritation in a patient when practice the procedure".It is unclear whether the irritation were located underneath the electrode respectively underneath the gel or surrounding foam area and of what severity the irritation was.No information about the nature of the procedure, the generator model, the power settings, the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us despite of repeated requests.

• Brand Name: SKINTACT
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 7697569
• Report Number: 8020045-2018-00012
• Device Sequence Number: 1108193
• Product Code: GEI
• UDI-Device Identifier: 19005531593241
• UDI-Public: (01)19005531593241
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2018
• Device Model Number: RS25A30
• Device Catalogue Number: RS25A30
• Device Lot Number: 161004-2404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other