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

Catalog Number N305

Device Problem Insufficient Information (3190)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Mild blister/excoriation found under left upper lead noted during infant's bath.Manufacturer response for radiolucent neolead, radiolucent neolead (per site reporter) all affected lots 2022-9033, -9034, -9035 were pulled from stock and returned to manufacturer.

• Brand Name: NEOLEAD RADIOLUCENT
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon pkwy; valencia CA 91355
• MDR Report Key: 16564899
• MDR Text Key: 311499672
• Report Number: 16564899
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N305
• Device Lot Number: 2022-9034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1