MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number FSTF

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot batch have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.No information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use was provided.No further information on the patient and the procedure using ecg electrodes have been made available to us.We have been informed by the initial reporter that i have no more further information from the hospital.Therefore no further conclusion can be drawn and we close the investigation.

Event Description

On (b)(6), 2021.We have been informed about an incident with ecg electrodes at (b)(6).Nhs foundation trust in (b)(6).Skintact electrodes model fstf were used.We receieved an mhra report stating that multiple patients had suffered multiple skin tears when removing the ecg electrodes.They were conveyed to hospital for removal of ecg dots and for treatment for wounds.No further details have been disclosed despite repeated requests.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 11432558
• MDR Text Key: 247076574
• Report Number: 8020045-2021-00007
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000381
• UDI-Public: (01)19005531000381
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2021

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 Date: 04/10/2021
• Device Model Number: FSTF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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): Other