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

Model Number RT34

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.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.No information how the skin was prepped has been provided so far.It is also unclear whether the observed skin rashes constitute injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.The reporter stated "we tried to obtain photos of skin rash but hospital refused due to privacy".The complainant reported that no further incidents have been reported.We therefore consider the investigation closed.Device not returned.

Event Description

On (b)(6) 2018, we have been informed about an incident with ecg electrodes at an unknown hospital, supposedly in (b)(6).Short term diagnostic electrodes model skintact rt34 were used.No lot number was provided.The complainant reported the electrodes caused skin rash to patients.The distributor tried to obtain photos of skin rash but the hospital refused due to their privacy policy.No further information on the patients and the skin preparation has been provided.

Event Description

On january 04th, 2018, we have been informed about an incident with ecg electrodes at an unknown hospital, supposedly in (b)(6).Short term diagnostic electrodes model skintact rt34 were used.We received a fully completed questionaire, dated march 08th, 2018.The user provided not specific data on a patient but related to an unknown number of affected patients.It was reported that the incidents occured during a period from (b)(6) to (b)(6) 2017.12 ecg electrodes were applied in the chest area for a 10-20 min ecg diagnosis procedure.No brand of ecg monitor was provided.No injury or skin lesion was present before applying the ecg electrodes.For most of the patients no skin preparation was performed: the "majority of patient have dry skin and no need to do skin preperation".It was reported that patients developed skin redness.The skin reactions were detected "directly on the sticky area" in the same size of the electrodes.The electrodes adhered properly.It was also mentioned that "several events were reported as difficult in peeling off the electrodes and skin redness was noted after removal.Patients complained of pain also noted especially patients with dry skin or delicated skin." the user facility confirmed that no medical intervention was necessary to treat the injuries.

Manufacturer Narrative

Retained samples of the same lot number were inspected visually and mechanically.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.No conclusion regarding the initial cause of the irritation can be drawn.The complainant reported that no further incidents have been reported.As no medical intervention was necessary to treat the injuries we conclude that these incidents are not reportable.We therefore consider the investigation closed.Device not returned.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 7230050
• MDR Text Key: 98625876
• Report Number: 8020045-2018-00001
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• PMA/PMN Number: K092291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: RT34
• Device Catalogue Number: 2000
• Device Lot Number: 70509-0641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other