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

Model Number W-601

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Retained and returned customer samples have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained and returned customer samples of the claimed lot number.All tested samples were found to perform within limits.No faults could be detected.The involved device has not been made available for an investigation.Despite several requests for further information none was made available.It is therefore unclear if the reported incident constitutes a patient injury which had to be treated afterwards.Due to lack of information no further investigation can be performed and therefore no conclusion regarding the cause of the skin reaction 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 an unknown hospital, reported from a customer located in (b)(6).Whitesensor electrodes model w-601 were used.The complainant reported "cust[omer] has reported issue with skin reactions, no details of patients or pictures.When rep[resentant] visited customer the technician put one on her hand and it went red almost instantly." we have requested further information on the patient, the skin preparation, if and how the skin injury had to be treated.

• Brand Name: WHITESENSOR
• 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: 9976316
• MDR Text Key: 190935272
• Report Number: 8020045-2020-00008
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 05707480036141
• UDI-Public: (01)05707480036141
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/20/2020

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: 07/08/2022
• Device Model Number: W-601
• Device Catalogue Number: CMM-00-S/30
• Device Lot Number: 190708-0251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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