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

Model Number PD-50 SFC

Device Problem No Apparent Adverse Event (3189)

Patient Problem Tissue Damage (2104)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

The retained samples have been tested visually and tested mechanically.The adhesive performance was also tested for 5 hours on two test persons.No faults could be detected.It can not be determined, why a hyperaemia has developed and why it has developed underneath only one of the three electrodes used.No further conclusion can be drawn on this incident.

Event Description

On (b)(6) 2019, we have been informed about an incident using ecg electrode at an unknown hospital in (b)(6).A cardiac functionality monitoring on a premature neonatal baby was carried on.The ecg electrodes (pd-50-sfc) were applied to the neonatal premature baby.Three electrodes had been used and were connected to a dräger infinity delta xl monitor.The patient body type was described as slim and the skin type as normal, no hair.The general state of the patient was described as normal.The skin of the baby was not cleaned, not disinfected, no ointment had been used but the skin was dried."during the treatment the patient showed hyperemia in abdominal area around the ecg electrode, after the treatment the customer discovered an hyperemic area with vesicle partially intact".The electrodes had been removed for a diaper change.The injury had been described as "hyperemic area with vesicle partially intact (second degree burn)" at the abdominal area.The size was described as "unique area of about 1.5 x 2 cm".The injury had been detected underneath the electrode."the customer contact the burn center and they treated the wound with amuchina, washing with physiologic solution and application of gauze with fusidic acid." we received a picture showing the injury dated (b)(6) 2019 and a further picture showing an apparently healed baby body dated (b)(6) 2019.

• 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: burrhus lang ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 8757200
• MDR Text Key: 149923555
• Report Number: 8020045-2019-00016
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 19005531000418
• UDI-Public: (01)19005531000418
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K080106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: PD-50 SFC
• Device Lot Number: 181201-0767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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 Weight: 1