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

Model Number TVO01

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed so far.The involved device has not been made available to us.No information on the patient, skin type, the skin preparation, state of skin, whether any medication was being taken, which might have a skin weakening effect and details of the use like the duration of wearing, how often the electrodes were changed was provided.Also no information was provided if and how the skin reaction had to be treated afterwards.We have requested further information.We will relay any further information in a follow up report.

Event Description

On august 06th, 2020 we have been informed about an incident involving ecg electrodes at a pharmacy located in a university medical center (b)(6).A monitoring procedure was performed using ecg electrodes (model skintact t-vo01) and a spiderflash-t afib device.The initial reporter provided the following information: "a patient undergoes a continuous electrocardiogram for seven days (with the spiderflash-t afib device).She used the skintact® t-vo01 offset ecg electrodes but developed an allergic reaction to the adhesive ring (she changes the electrodes if she takes a shower or bath).Which alternative electrode is compatible with the device for the described use and sensitive skin, avoiding the adhesive ring." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us.

Manufacturer Narrative

As neither a lot number nor samples have been made available to us, no analyses could be performed so far.The involved device has not been made available to us.No information on the patient, skin type, the skin preparation, state of skin, whether any medication was being taken, which might have a skin weakening effect and details of the use like the duration of wearing, how often the electrodes were changed was provided.Also no information was provided if and how the skin reaction had to be treated afterwards.After several requests we have been informed that: "i've checked with the patient.It was a light and local allergy to the electrodes, but she doesn't want to give more information about this case or her personal data." no conclusion can be drawn what might have caused the patient problem.We therefore consider the investigation closed.

Event Description

On (b)(6) 2020 we have been informed about an incident involving ecg electrodes at a pharmacy located in a university medical center (unisanté) in lausanne, switzerland.A monitoring procedure was performed using ecg electrodes (model skintact t-vo01) and a spiderflash-t afib device.The initial reporter provided the following information: "a patient undergoes a continuous electrocardiogram for seven days (with the spiderflash-t afib device).She used the skintact® t-vo01 offset ecg electrodes but developed an allergic reaction to the adhesive ring (she changes the electrodes if she takes a shower or bath).Which alternative electrode is compatible with the device for the described use and sensitive skin, avoiding the adhesive ring." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 10429622
• MDR Text Key: 203905480
• Report Number: 8020045-2020-00019
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TVO01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other