ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4408 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-03 for ULTRALITE FULL BODY PHOTOTHERAPY UNIT V4408 NA manufactured by Ultralite Enterprises, Inc.

Event Text Entries

[207141] Pt receiving treatment by the medical device received 2nd degree blistering burns on chest, abdomen and inner thigh.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1045025-2001-00005
• MDR Report Key: 339902
• Report Source: 05
• Date Received: 2001-07-03
• Date of Report: 1994-05-25
• Date of Event: 1994-05-23
• Date Mfgr Received: 1994-05-25
• Device Manufacturer Date: 1992-12-01
• Date Added to Maude: 2001-07-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: WILLIAM MCMILLAN
• Manufacturer Street: 390 FARMER COURT
• Manufacturer City: LAWRENCEVILLE GA 30045
• Manufacturer Country: US
• Manufacturer Postal: 30045
• Manufacturer Phone: 7709630594
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRALITE FULL BODY PHOTOTHERAPY UNIT
• Generic Name: ULTRAVIOLET DERMATOLOGICAL LIGHT
• Product Code: KGL
• Date Received: 2001-07-03
• Model Number: V4408
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 329226
• Manufacturer: ULTRALITE ENTERPRISES, INC
• Manufacturer Address: 390 FARMER COURT LAWRENCEVILLE GA 30045 US
• Baseline Brand Name: ULTRALITE FULL BODY PHOTOTHERAPY UNIT
• Baseline Generic Name: ULTRAVIOLET DERMATOLOGICAL LIGHT
• Baseline Model No: V4408
• Baseline Catalog No: NA
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-07-03