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

Model Number	W-601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 9976316
• Report Number: 8020045-2020-00008
• Device Sequence Number: 16666435
• Product Code: DRX
• UDI-Device Identifier: 05707480036141
• UDI-Public: (01)05707480036141
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K023503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other