MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; MULTIFUNCTION DEFIBRILLATION ELECTRODE

Model Number DF20N

Device Problem Missing Information (4053)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the usa.No 510 (k) and no pma exist for it.However, devices made using a similar design are sold in the us.We are therefore reporting this incident.As neither a lot number nor samples have been made available to us, no analyses could be performed so far.No investigation could be carried out based on the information provided.No information was provided about the patient, skin type, skin condition, possible skin preparation, taken medications that could have a skin-weakening effect, duration of use, details of the application and the health consequences for the patient who could not be defibrillated.On march 7th, 2024 we have been informed that "i confirm to you, after consultation with the user, that we will not receive any further information about the complaint.After consultation with the user, the complaint is now closed.No more further problems have been noted with subsequent deliveries." we have repeatedly asked for further information, in particular regarding the health consequences for the patient, as well as samples and the involved lot number and have not received any (questionnaire and requested information) despite repeated requests.No conclusion can be drawn what might have caused the claimed malfunction.We therefore consider the investigation and the complaint to be closed.

Event Description

On february 22nd, 2024, we have been informed about a malfunction with a skintact defibrillation electrode set at schüchtermann klinik gmbh & co.Kg in germany.Skintact defibrillation electrodes model skintact df20n, lot number: unknown and an unknown defibrillator had been used.The initial report was stating that [translated from german language to english language "we received information from a customer that the df20n has been causing more problems since the size has changed.According to the customer, every patient experienced skin irritation after defibrillation and one patient, who had a bmi of 34, could not be defibrillated at all".Despite repeated requests no further details have been disclosed.

• Brand Name: SKINTACT
• Type of Device: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 19131743
• MDR Text Key: 341466301
• Report Number: 8020045-2024-00010
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 19005531501137
• UDI-Public: (01)19005531501137
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DF20N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other