FDA.reportPublic FDA data

MAUDE MDR 520342

MDR report key
520342
Report number
1045025-2004-00001
Event key
0
Event type
3
Date of event
2003-01-21
Date received
2004-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
* * *
Phone
963-963-9630
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRALITE FULL BODY PHOTOTHERAPY UNITUV DERMATOLOGY LIGHTULTRALITE ENTERPRISES, INC.KGLNOT REPORTEDNOT REPORTEDNANR*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-04-0801. O; 2. R

Event Narratives#

D

Patient 1

ULTRALITE ENTERPRISES, INC. BECAME AWARE OF AN EVENT THAT OCCURRED IN 1/2003, THROUGH CORRESPONDENCE FROM AN ATTORNEY. THE ATTORNEY STATES HIS CLIENT RECEIVED BURNS. AT A UNIVERSITY PHOTOTHERAPY DEPT. USING ULTRALITE EQUIPMENT. NO MODEL NUMBER, SERIAL NUMBER OR FURTHER INFO WAS GIVEN. IT WAS DECIDED THAT AN MDR SHOULD BE FILED.