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

Model Number FS-RE /6

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Retained samples have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The incident is reported because it is unknown if and how the skin reaction had to be treated.The incident might not constitute a reportable event.Despite several requests for further information none was available.Due to lack of information no further investigation can be performed and therfore no conclusion regarding the cause of the skin injury can be drawn.We therefore close the investigation.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at the (b)(6).Skintact electrodes model fs-re /6 were used.The complainant reported "i recently had a patient that had quite a considerable allergic reaction to the ecg electrodes.They were only on during a relativity short scan and removed directly after." we have requested further information on the patient, the skin preparation, allergies that the patient has, if and how the skin injury had to be treated.

• 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: 9871313
• MDR Text Key: 190934207
• Report Number: 8020045-2020-00004
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000272
• UDI-Public: (01)19005531000272
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: FS-RE /6
• Device Lot Number: 191106-0344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2019
• 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