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

Model Number FS-VM01

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 01/26/2019

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot number were inspected visually, electrically and mechanically.All electrodes were within limits, no failure could be detected.No conclusion can be drawn as to why a skin tear occurred when removing one electrode.Based on the information available and the involved electrode not having been made available no further investigations can be performed.We therefore close the investigation.

Event Description

On (b)(4) 2019, we have been informed about an incident with ecg electrodes at (b)(6).Monitoring ecg electrodes (model skintact fs-vm01) and a zoll heart monitoring recorder had been used.A 1 minute monitoring was performed.The patient was being treated for cancer of the lung.The general state of the patient at the time the incident occured were described as him having chest pains.It was described that a 12 lead ecg procedure was performed at the patient's home.Ten electrodes were applied to the patient.The patient's skin type was described as dry.The skin was not shaven, not disinfected, no ointment had been used.The electrodes were adhering properly to the patient.The reporter stated "when the crew were removing electrodes after ecg" (.) skin pulled away from patients (.) left forearm".The position of the electrode relative to the injury was reported as "in the middle af the contact area" of the electrode.The injury was described as a "2cm x 2cm skin tear presumed round".All other nine electrodes were removed without issues.The injury was "cleaned and dressed by a+e".It was reported that the "wound is healing well.On (b)(6) 2019 dressing removed + smaller lighter wound care applied".

• Brand Name: SKINTACT
• Type of Device: ECG 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: burrhus lang ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 8357175
• MDR Text Key: 136725957
• Report Number: 8020045-2019-00003
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 190005531000173
• UDI-Public: (01)190005531000173
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

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: 12/14/2020
• Device Model Number: FS-VM01
• Device Lot Number: 181214-0234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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
• Patient Age: 64 YR