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

Model Number FSVF01

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot 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.Skin tear of the nature described can be caused by the adhesive and by the state of the skin itself.Certain medical conditions (like diabetes) and certain medication (like steroids) can weaken the skin.Information to this extent along with the age of the patient would be crucial to investigate, whether this has played any role.Unfortunately it was not provided.After requesting several times for further information on the patient none had been made available.The initial reporter stated "(.) we will have to close with all the info we have (.)".Therefore no further conclusion can be drawn what might have caused the incident.We therefore will close the investigation.

Event Description

On (b)(6) 2021, we have been informed about an incident with ecg electrodes at nuffield health leeds hospital in (b)(6).Skintact electrodes model fsvf01 were used.We received an mhra report providing the following information: "details of incident / nature of device defect test patient attended for consultation and additional pacemaker interrogation.Patient was connected to 4 lead ecg on abbott programmer, using skintact ecg electrodes.Upon completion of device interrogation, cardiac physiologist and patient were unable to remove one of the ecg electrodes from patient's right arm.Consultant attempted but was also unable to remove electrode, so suggested we submerge patient's arm in water to loose the adhesive material.Patient's arm was submerged for 5-10 minutes and consultant was able to remove electrode although notably it caused pain and broke skin on patient's arm.Details of injury (.): significant tear in patient skin around area where electrode had been attached.Required full dressing, applied by consultant.Action taken (.) patient provided with appropriate wound care supplies / dressing and advised on how to obtain follow-up care.Consultant contacted patient following week and wound was healing well.Remaining electrodes removed from stores and supplies manager reported to manufacturer." 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: 11391394
• MDR Text Key: 243463292
• Report Number: 8020045-2021-00006
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000593
• UDI-Public: (01)19005531000593
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: FSVF01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2020
• 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