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

Model Number	DF20N
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retained samples of the concerned lot number (260123-4044) have been inspected visually.All samples were within limits, no failure could be detected.We have requested the involved sample for investigation of the root cause for the compromized packaging.Currently the involved sample has not been made available to us by the date of this report.We therefore will relay any further investigation result in a follow up report.
Event or Problem Description
On (b)(6) 2026, we have been informed by a customer about a failure with a defibrillation electrode set.Skintact defibrillation electrodes our model df20n had been detected as defective.The initial report is stating that: "the packaging bag is not sealed." we also received one picture showing the claimed defect.Reviewing the customer picture it is visible an unsealed pouch sealing at the top of the pouch.For a further root cause analyses, we have requested the concerned customer pouch.No further details have been disclosed so far.
Event or Problem Description
On march 05th, 2026, we have been informed by a customer about a failure with a defibrillation electrode set.Skintact defibrillation electrodes our model df20n had been detected as defective.The initial report is stating that: "the packaging bag is not sealed." we also received one picture showing the claimed defect.Reviewing the customer picture it is visible an unsealed pouch sealing at the top of the pouch.Neither further details nor the concerned customer pouch have been provided despite requests.
Additional Manufacturer Narrative
Retained samples of the concerned lot number (260123-4044) have been inspected visually.All samples were within limits, no failure could be detected.We have requested the involved sample for investigation of the root cause for the compromised packaging.The involved sample was not available for an investigation.It is not clearly visible in the customer picture, but we assume that the pouch was not sealed as no sealing impressions are visible in the pouch material.We have examined the assembly and testing equipment in the concerned production line.The failure was most probably caused by production employee handling not following the correct flow of goods.As a corrective action we have originated a capa to improve the handling within the production line.However the claimed failure is an apparent damage to the product pouch.The instructions for use state the following: "caution (.) inspect packaging, electrode, cable and connector prior to use.Do not use if compromised." we assume this to be a single error and consider the investigation and the report to be closed.

• Brand Name: SKINTACT
• Common Device Name: MULTIFUNCTION DEFIBRILLATION ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: thomas recheis ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 24725945
• Report Number: 8020045-2026-00010
• Device Sequence Number: 16000437
• Product Code: MKJ
• UDI-Device Identifier: 19005531501130
• UDI-Public: (01)19005531501130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 142803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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
• Operator of Device: Health Professional
• Device Model Number: DF20N
• Device Lot Number: 260123-4044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown