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

Model Number FS-TF/6

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

Retained and returned samples have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained and returned 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.After several requests for further information we have been informed by the initial reporter that "there will be no questionnaire unfortunately".Due to lack of information no further investigation can be performed and therefore no conclusion regarding the cause of the skin injury can be drawn.We therefore close the investigation.

Event Description

On november 06th, 2019, we have been informed about an incident with ecg electrodes at an unknown hospital in uk.Skintact electrodes model fs-tf/6 were used.The complainant reported "we have had a complaint about fs-tf/6, leaving a red mark on the patients skin." we have requested further information on the patient, the skin preparation, the duration of wearing 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, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 9414916
• MDR Text Key: 169483668
• Report Number: 8020045-2019-00029
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Model Number: FS-TF/6
• Device Lot Number: 190909-0348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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