UV BIOTEK 3200NB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-19 for UV BIOTEK 3200NB manufactured by Uv Biotek.

Event Text Entries

[21013735] There was a power outage in the building from (b)(6)2010. The power was restored on (b)(6)2010 by 11:30 or so pm. Ours is a dermatology practice. We use light therapy for various disorders. Our light box is made by uv biotek. We have used it for the last four years with no problems. On (b)(6)2010, my staff placed an (b)(6) child in the light box for one minute and 15 seconds. The light failed to turn off. A staff member realized this and turned the light off manually. The child was given about a three minute dose. Normally the safety shut off should deliver only the amount of light that is pre set by the timer. For some reason on this day, the light box failed to shut down as it usually does. This is highly unusual. We suspect an electrical problem. The child developed marked erythema on the face and areas of vitiligo and a small irregular shaped patch of solar burn on the left buttock. By (b)(6)2010, he had pain on the buttock only and blanching erythema but no tenderness elsewhere and the facial erythema had nearly resolved. Dates of use: (b)(6)2006 - (b)(6)2010. Diagnosis or reason for use: vitiligo, psoriasis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5017185
• MDR Report Key: 1813796
• Date Received: 2010-08-19
• Date of Report: 2010-08-19
• Date of Event: 2010-08-17
• Date Added to Maude: 2010-08-27
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UV BIOTEK
• Generic Name: PHOTOTHERAPY UNIT
• Product Code: FTC
• Date Received: 2010-08-19
• Returned To Mfg: 2010-08-26
• Model Number: 3200NB
• ID Number: 61778
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UV BIOTEK
• Manufacturer Address: NORTH FORT MEYERS FL US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-08-19