MAUDE Adverse Event Report: LEADS; ELECTRODE, CUTANEOUS

Lot Number 051972

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 07/15/2022

Event Type  Injury  

Event Description

A 3 year-old male presented to pediatric unit for removal of electrodes from a three day ambulatory eeg (electroencephalogram) procedures.When the tech removed the lead the tech noticed the skin showed blistering, irritation and redness.Presents to ed (emergency department) for skin irritation/reaction to eeg leads.Fda safety report id# (b)(4).

• Brand Name: LEADS
• Type of Device: ELECTRODE, CUTANEOUS
• MDR Report Key: 15121686
• MDR Text Key: 296866287
• Report Number: MW5111162
• Device Sequence Number: 2
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/26/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 051972
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUPREP-07/13/2022-07/15/2022; TEN20-7/13/2022-07/15/2022
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 18 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White