MAUDE MDR 357393

MDR report key: 357393
Report number: 1045025-2001-00009
Event key: 0
Event type: 3
Date of event: 2001-04-01
Date received: 2001-08-31
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

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 DERMATOLOGY LIGHT	ULTRALITE ENTERPRISES, INC.	KGL	V4408	NA	UNK			N	Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-08-31	0	1. O

Event Narratives#

D

Patient 1

UEI 1ST REPORT OF INJURY, IN 2001 FROM PT'S SPOUSE. PT'S SPOUSE STATES,PT BURNED TWICE BY UNIT. UEI CALLED FACILITY.SUPERVISOR AT FACILITY STATED, UEI WAS NOT CALLED BECAUSE PT WAS NOT BURNED GREATER THAN A SUNBURN, AND IN 2001 WAS 1ST TREATMENT AND SUNBURNS ARE COMMON SIDE AFFECT OF TREATMENT. NSG. SUPERVISOR ALSO STATED THAT PT GOING TO TANNING SALON IN BETWEEN TREATMENTS. NSG. SUPERVISOR ALSO STATED PT WENT TO HOSPITAL AFTER 4/2001 BECAUSE FAMILY INSISTED. (PT ON DIALYSIS ).

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

MAUDE MDR 357393

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related PMN/PMA Records By Product Code#