MAUDE MDR 1813796

MDR report key
1813796
Report number
MW5017185
Event key
0
Event type
3
Date of event
2010-08-17
Date received
2010-08-19
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UV BIOTEKPHOTOTHERAPY UNITUV BIOTEKFTC3200NB R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-08-1901. O

Event Narratives#

D

Patient 1

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.