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

Catalog Number N305

Device Problem Use of Device Problem (1670)

Patient Problems Blister (4537); Unspecified Tissue Injury (4559)

Event Date 03/08/2023

Event Type  No Answer Provided  

Event Description

Blisters/skin injury found under ekg leads when they were removed for infants bath.Manufacturer response for radiolucent neolead ecg electrodes, radiolucent neolead ecg electrodes.(per site reporter).

• Brand Name: NEOLEAD RADIOLUCENT
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon pkwy; valencia CA 91355
• MDR Report Key: 16564823
• MDR Text Key: 311506781
• Report Number: 16564823
• 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

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: N305
• Device Lot Number: 2002-9035
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1