MAUDE Adverse Event Report: NEOTECH PRODUCTS, LLC NEOLEAD ECG ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number N301

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 06/09/2022

Event Type  Injury  

Event Description

Chest excoriation and redness due to ekg leads.Fda safety report id# (b)(4).

• Brand Name: NEOLEAD ECG ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): NEOTECH PRODUCTS, LLC
• MDR Report Key: 15163453
• MDR Text Key: 297323273
• Report Number: MW5111257
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2022

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 Model Number: N301
• Device Lot Number: 2022-9003
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2022
• Patient Sequence Number: 1
• Patient Age: 6 WK
• Patient Sex: Male