* 5400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-25 for * 5400 manufactured by Neuromedics Henley Healtcare.

Event Text Entries

[267073] Preterm infant at 33+ weeks gestation in nicu sustained superficial burns to left hand and left foot from transluminator which was used for assist in iv access.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026250
• MDR Report Key: 418790
• Date Received: 2002-09-25
• Date of Report: 2002-09-18
• Date of Event: 2002-07-26
• Date Added to Maude: 2002-09-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: TRANSILLUMINATOR
• Product Code: FTG
• Date Received: 2002-09-25
• Model Number: 5400
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 407815
• Manufacturer: NEUROMEDICS HENLEY HEALTCARE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-09-25