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

Model Number T-602

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

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.It is yet unknown whether the skin reaction occurred underneath the electrode's tape or underneath it's gel.No information how the skin was prepped has been provided so far.It is also unclear whether the skin reactions constitute injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.We will continue to request further information and will provide any findings in a follow up report.

Event Description

On september 14th, 2017, we have been informed about a skin reaction during an ecg procedure.Monitoring ecg electrodes model skintact t-602 have been used.The initial report stated that "unfortunately one of our patients has developed a nasty allergic reaction to the electrode used and has been seen by a dermatologist who has asked for details of the composition/material of the adhesive used." no further details have been disclosed so far despite of repeated requests.

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.It is yet unknown whether the skin reaction occurred underneath the electrode's tape or underneath it's gel.No information how the skin was prepped has been provided so far.It is also unclear whether the skin reactions constitute injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.Our distributor informed us on jan 03, 2018, that no further information will be available "we did not receive a completed adverse events questionnaire so there's not a lot we can do to progress this investigation.We have not had any information or contact with the customer since (b)(6) 2017 therefore we have decided to close this complaint." we therefore consider the investigation closed and also close the complaint.

Event Description

On september 14th, 2017, we have been informed about a skin reaction during an ecg procedure.Monitoring ecg electrodes model skintact t-602 have been used.The intital report stated that "unfortunately one of our patients has developed a nasty allergic reaction to the electrode used and has been seen by a dermatologist who has asked for details of the composition/material of the adhesive used." no further details have been disclosed so far despite of repeated requests.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: burrhus lang ; archenweg 56; innsbruck, tirol 6020 ; AU 6020 ; 5123342541
• MDR Report Key: 6944093
• MDR Text Key: 89296780
• Report Number: 8020045-2017-00024
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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: 10/31/2019
• Device Model Number: T-602
• Device Lot Number: 161018-0252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other