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

Model Number FS-50

Device Problem Insufficient Information (3190)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443); Localized Skin Lesion (4542)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot numbers 200505-0097 and 200304-0096 have been inspected visually and tested mechanically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.The incident is reported because it is unknown if and how the skin reaction had to be treated.The incident might not constitute a reportable event.However we have requested further information on the incidents and will relay any information in a follow up report.

Event Description

On september 02nd, 2020, we have been informed about incidents with ecg electrodes (model fs-50) at (b)(6).The complainant reported "our customer has experienced during stress ecg difficulties to get a high quality ecg.They are experiencing baseline fluctuation (the ecg curve is wandering) with disturbance already during the early rest phase.During exercise the electrode detaches easily.We clarified that the customer is preparing the skin appropriately (preparing the skin with alcohol, razoring (if needed) and scratching the skin) before attaching the ecg electrode.They also tell us that they apply the electrode carefully by pressing only the glue side of the electrode and not touching the center (wet gel) part of the electrode.The customer has also experienced similar issues in the ambulance environment; the electrodes detaches easily and also baseline fluctuation on the ecg curve.However, with elderly patient the electrodes has also caused skin damage because the electrodes are too tight to come off.The customer in hospital environment also reports incidents where the electrodes are hard to detach and causes skin damage to the patient while detaching the electrodes." no further information was provided on the patient, the skin preparation, the duration of wearing, if and how the skin injuries had to be treated.

Event Description

On (b)(6) 2020, we have been informed about incidents with ecg electrodes (model fs-50) at mediq suomi in finland.The complainant reported "our customer has experienced during stress ecg difficulties to get a high quality ecg.They are experiencing baseline fluctuation (the ecg curve is wandering) with disturbance already during the early rest phase.During exersize the electrode detaches easily.We clarified that the customer is preparing the skin appropriately (preparing the skin with alcohol, razoring (if needed) and scratching the skin) before attaching the ecg electrode.They also tell us that they apply the electrode carefully by pressing only the glue side of the electrode and not touching the center (wet gel) part of the electrode.The customer has also experienced similar issues in the ambulance environment; the electrodes detaches easily and also baseline fluctuation on the ecg curve.However, with elderly patient the electrodes has also caused skin damage because the electrodes are too tight to come off.The customer in hospital environment also reports incidents where the electrodes are hard to detach and causes skin damage to the patient while detaching the electrodes.(.)" no further information was provided on the patient, the skin preparation, the duration of wearing, if and how the skin injuries had to be treated.

Manufacturer Narrative

Retained samples of the concerned lot numbers 200505-0097 and 200304-0096 have been inspected visually and tested electrically and mechanically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.On (b)(6) 2020 we received from the user one original closed pouch of the concerned lot number 200505-0097 for further investigation.The customer samples have been inspected visually and tested electrically and mechanically.All tested samples were found to perform within limits.No faults could be detected.No information was provided if and how the skin reaction had to be treated.It is therefore unclear whether the incident constitutes a reportable event.Despite of several requests for further information on the injury and its treatment we have not received any.No further analysis could be performed and no further conclusion can be drawn.We 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: 10604527
• MDR Text Key: 209138870
• Report Number: 8020045-2020-00022
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531580286
• UDI-Public: (01)19005531580286
• 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: 11/25/2020

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: 05/05/2022
• Device Model Number: FS-50
• Device Lot Number: 200505-0097
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other