MAUDE Adverse Event Report: LEONHARD LANG GMBH TRACE1; ECG ELECTRODE

Model Number FS-TA

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Type  Injury  

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 patient 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 incident 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 receive additional information.

Event Description

On (b)(6) 2022, we have been informed about an incident with ecg electrodes at an unknown hospital presumably in the us.Trace1 electrodes catalogue #5560 (model fs-ta) were used.The initial reporter was specifying "the electrodes are very sticky and harsh to the skin.A patient sustained a very superficial abrasion and developed redness from the electrode site." no further details have been disclosed despite repeated requests.

Event Description

On january 31th, 2022, we have been informed about an incident with ecg electrodes at an unknown hospital presumably in the us.Trace1 electrodes catalogue #5560 (model fs-ta) were used.The initial reporter was specifying " the electrodes are very sticky and harsh to the skin.A patient sustained a very superficial abrasion and developed redness from the electrode site." 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 patient 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 incident 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 have repeatedly requested for further information and have none received to the date of this report.We therefore consider the investigation to be closed.

• Brand Name: TRACE1
• 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: 13647125
• MDR Text Key: 287343880
• Report Number: 8020045-2022-00004
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10853512006411
• UDI-Public: (01)10853512006411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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: 09/01/2022
• Device Model Number: FS-TA
• Device Catalogue Number: #5560
• Device Lot Number: 200901-0299
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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