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

Model Number F-55

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerened lots (201103-0171 and 201105-0172) have been inspected visually.Mechanical tests were performed on 3 retained samples each lot number.All tested samples were found to perform within limits.No faults could be detected.We received customer samples of the lot number 201105-0172 for further investigation.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 reactions 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 germany.Ecg electrodes model patz f-55 were used.The initial reporter stated that in april he had had [allergic] reactions from customers who asked whether the composition of the adhesive or the gel had changed for the electrodes patz f-55.No further details have been disclosed despite repeated requests.

Manufacturer Narrative

Retained samples of the concerned lots (201103-0171 and 201105-0172) have been inspected visually.Mechanical tests were performed on 3 retained samples each lot number.All tested samples were found to perform within limits.No faults could be detected.We received customer samples of the lot number 201105-0172 for further investigation.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.It was reported in the provided questionnaire that no medical intervention was necessary to treat the patient injuries.We therefore assume that the incidents do not constitute reportable events.However the ifu explicitly states a precaution "do not use solvents to clean skin prior to ecg because solvents trapped under electrodes may lead to abnormal skin reactions." we therefore assume that the cleaning of the skin with medical bezine might have caused or contributed to the claimed patient injuries.No further conclusion can be drawn.We therefore close the investigation.

Event Description

On april 21st, 2021, we have been informed about an incident with ecg electrodes at an unknown healthcare facility in germany.Ecg electrodes model patz f-55 were used.The initial reporter stated that in april he had [allergic] reactions from customers who asked whether the composition of the adhesive or the gel had changed for the electrodes patz f-55.We have requested further information and received on june 16th, 2021 a filled in questionnaire.The filled in questionnaire was provided for several patients.The filled in questionnaire belongs to male and female patients.The patients were described as of normal weight with less to no body hair.The general status of the patients were described as normal.The skin type was described as normal.The skin was cleaned with medical benzine, not shaven, not disinfection not dried and no ointment had been used before applying the ecg electrodes.During every monitoring 5 electrodes had been used each patient.It was also stated that 1-2 electrodes caused each patient injuries.The monitoring procedure was described as long term monitoring lasting for 24 hours.Directly after the monitoring procedure skin redness and slight blisters have been detected.It was also reported that no treatment of the injury was necessary.

• Brand Name: PATZ
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 11839776
• MDR Text Key: 253830245
• Report Number: 8020045-2021-00015
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K024247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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: 11/05/2022
• Device Model Number: F-55
• Device Catalogue Number: K999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other