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

Model Number W-602

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerened lot number have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.No information on the patients, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use was provided.No conclusion regarding the cause of the allergic reaction can be drawn.The incident is reported because it is unknown if and how the skin injury had to be treated.The incident might not constitute a reportable event.We will provide a follow up report when we will recieve additional information.

Event Description

On (b)(6), 2021, we have been informed about an incident with ecg electrodes at an unkown healthcare facility in (b)(6).Skintact electrodes model w-602 were used.The initial reporter stated that the hospital is concerned over a number of reactions by several different patients to the w602 electrode over the last few months.The customer said the reactions resulted in very severe rashes not only directly to where the electrodes were applied but all around them.No further details have been disclosed despite repeated requests.

Manufacturer Narrative

Retained samples of the concerned lot number have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.No information on the patients, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use was provided.No conclusion regarding the cause of the allergic reaction can be drawn.The incident is reported because it is unknown if and how the skin injury had to be treated.The incident might not constitute a reportable event.We repeatedly have requested for further information and have been informed that "we have followed up with the customer and unfortunately we have been advised that they are unable to complete the questionnaire as the person who originally made the complaint is not available." we therefore consider the investigation and the complaint closed.

Event Description

On (b)(6) 2021, we have been informed about an incident with ecg electrodes at an unknown healthcare facility in ireland.Skintact electrodes model w-602 were used.The initial reporter stated that the hospital is concerned over a number of reactions by several different patients to the w602 electrode over the last few months.The customer said the reactions resulted in very severe rashes not only directly to where the electrodes were applied but all around them.No further details have been disclosed despite repeated requests.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 11839778
• MDR Text Key: 253711301
• Report Number: 8020045-2021-00017
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 29005531000944
• UDI-Public: (01)29005531000944
• Combination Product (y/n): N
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: 01/29/2023
• Device Model Number: W-602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other