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

Model Number RT38

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

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 might not constitute a reportable event however as it was stated in the initial report "no [patient harm occurred] but occurence is likely".We will continue to request for further information and samples for a testing and relay any information in a follow up report.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at (b)(6) in (b)(6).Skintact electrodes model rt38 were used.The complainant reported "this item is to sticky for elderly & babies as staff have trouble taking of elderly patients & babies as it pulls the skin also other times they do not stick at all".We have requested further information on the patients, the skin preparation, if and how the skin injury had to be treated.

Event Description

On march 20th, 2020, we have been informed about an incident with ecg electrodes at (b)(6) hospital, nhs foundation trust, in uk.Skintact electrodes model rt38 were used.The complainant reported "this item is to sticky for elderly & babies as staff have trouble taking of elderly patients & babies as it pulls the skin also other times they do not stick at all".We have requested further information on the patients, the skin preparation, if and how the skin injury had to be treated.

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 might not constitute a reportable event however as it was stated in the initial report "no [patient harm occurred] but occurence is likely." we have repeatedly requested further information and the concerned device but have not received any.The distributor and initial reporter has informed us that "supply chain have now closed this complaint because of incorrect information and lack of contact, please close on your end." no conclusion can be drawn what might have caused the patients' problems.We will therefore close the investigation.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 9961335
• MDR Text Key: 190934908
• Report Number: 8020045-2020-00007
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531001122
• UDI-Public: (01)19005531001122
• Combination Product (y/n): N
• PMA/PMN Number: K092291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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: 02/04/2023
• Device Model Number: RT38
• Device Lot Number: 200204-0644
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other