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

Model Number FSTB1

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

As no lot number has been provided, no tests could be performed on retained samples.It is unknown whether the skin reaction occurred underneath the electrode's foam tape or underneath it's gel.It is also unclear whether the skin reaction constitutes an injury and whether it had to be treated.It was not possible to receive this information despite repeated requests.We judge a "skin reaction" as no permanent impairment of the skin.However we decided to report this incident to err on the safe side.We will follow up when we receive further information.Device not returned.

Event Description

On (b)(6) 2017, we have been informed by (b)(6), about an incident involving skintact fstb1 ecg electrodes.The complainant reported: "i was just using your product, fs-tb1, with a client and we found that upon removal of the electrode pad, the client had a skin reaction to the adhesive.She reports that she has a slight sensitivity to latex, not an allergy, but we did see that the packaging indicates this product does not contain latex.I am hoping you can give me some more information about the adhesive used on these products (on the pad itself, not the center gel) so that i may be aware of this and inform my clients in the future about potential skin irritants." no further information on the patients, the skin preparation, the duration of application and the position of the skin reaction relative to the electrode has been provided.

Event Description

On november 07th, 2017, we have been informed by (b)(6), about an incident involving skintact fstb1 ecg electrodes.The complainant reported: "i was just using your product, fs-tb1, with a client and we found that upon removal of the electrode pad, the client had a skin reaction to the adhesive.She reports that she has a slight sensitivity to latex, not an allergy, but we did see that the packaging indicates this product does not contain latex.I am hoping you can give me some more information about the adhesive used on these products (on the pad itself, not the center gel) so that i may be aware of this and inform my clients in the future about potential skin irritants." complainant update: "the lot number that was affected was #161129-0378.The electrodes were placed on the skin of her forearm for approximately 20 minutes while we recorded her muscle emg (electromyograph).This procedure was a part of a research experiment, so the person in question was not a patient.I followed up with her after the procedure and she said that within 2-3 hours the irritation had subsided and she only had slight redness, which did not last longer than a day.In our follow up conversation, she mentioned that the reaction seemed to be simply irritation resulting from contact with strong adhesive, rather than a specific reaction to a component of the adhesive.I contacted your company right away because i planned to use these products with multiple clients in the future and wanted to ensure that there was nothing with this specific lot that was causing irritation.From my later conversation with the client, and further use of the sticky pads on myself for testing, i think the reaction was due to the strength of the adhesive (.)".No further information on the patient and the skin preparation, has been provided.

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanicaly.In addition, two electrodes were applied on a volunteer for six hours.No reaction or deviation could be observed.The retained samples were within specification.The complainant states "she said that within 2-3 hours the irritation had subsided and she only had slight redness, which did not last longer than a day.In our follow up conversation, she mentioned that the reaction seemed to be simply irritation resulting from contact with strong adhesive, rather than a specific reaction to a component of the adhesive." based on the provided information we conclude that this incident is not reportable anymore and we therefore close the investigation.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 7137502
• MDR Text Key: 95460964
• Report Number: 8020045-2017-00028
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: FSTB1
• Device Lot Number: 161129-0378
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other