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

Model Number FS-321

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

Retained samples of the concerned lot were inspected visually and tested mechanically.The mechanical tests were performed on 3 retained samples.All tested electrodes were within limits, no failure could be detected.The involved device has not been made available for an investigation.The whole production volume of this lot was (b)(4) electrodes and we have not received any further complaint on this concerned lot number.We therefore assume based on the results of the product tests and the information provided in the questionnaire that the patient condition might have caused or contributed to the incident.No further conclusion can be drawn.We therefore close the investigation.

Event Description

On (b)(6) 2020, we have been informed about an incident with ecg electrodes at (b)(6) in (b)(6).Skintact ecg electrodes (model fs321) were used.We have requested further information and received a completed questionnaire.A 10 minutes 3 lead "ecg monitoring before vaccine administration" was performed.The patient was described as normal.The skin type was described as dry skin.The medical history of the patient was described as food allergies: milk,egg, wheat, peanut and a vaccine allergy to mmr vaccine.The skin was not cleaned, not shaven, not disinfection and no ointment had been used but have been dried before applying the ecg electrode.3 electrodes were applied in total to the patient.The electrodes were placed on the patient's chest.During the treatment an injury was discovered.The injury was described as urticarial rash in size of about 13 x 13cm on the chest and the eyelids.The injury was treated with "dexamethasone iv injection, cpm iv injection.(stands for chlorpheniramine)".

• 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, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 9914772
• MDR Text Key: 190934535
• Report Number: 8020045-2020-00005
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000746
• UDI-Public: (01)19005531000746
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: FS-321
• Device Lot Number: 171024-0082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• 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
• Patient Age: 1 YR
• Patient Weight: 12