MAUDE MDR 339907

MDR report key: 339907
Report number: 1045025-2001-00006
Event key: 0
Event type: 3
Date of event: 1994-04-06
Date received: 2001-07-03
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: WILLIAM MCMILLAN
Address: 390 FARMER COURT LAWRENCEVILLE GA 30045 US
Phone: 770-770-7709
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	ULTRALITE FULL BODY PHOTOTHERAPY UNIT	ULTRAVIOLET DERMATOLOGICAL LIGHT	ULTRALITE ENTERPRISES, INC	KGL	V4408	NA	NA			N	Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-07-03	0	1. O

Event Narratives#

D

Patient 1

PT RECEIVING TREATMENT BY MEDICAL DEVICE RECEIVED 2ND DEGREE BLISTERING BURNS ON FEET.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K852575	KGL	WALDMANN F85/100W PUVA	Sylvania Lighting Products	1985-08-16
510(k)	K841795	KGL	UV 8001K, PUVA 800, PUVA 180/200 1000	Waldmann Lighting Co.	1984-08-30
510(k)	K820280	KGL	SPECTRA 305/350	Ultralite	1982-03-05
510(k)	K810668	KGL	HO-B-LITE VI UNIT	National Biological Corp.	1981-04-23
510(k)	K810358	KGL	PHOTOTHERAPY LIGHT CHAMBER	Paul B. Elder Co.	1981-03-20