FDA.reportPublic FDA data

MAUDE MDR 3360439

MDR report key
3360439
Report number
MW5031903
Event key
0
Event type
3
Date of event
2013-07-23
Date received
2013-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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 LIGHTUV LIGHTMXG

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-09-180

Event Narratives#

D

Patient 1

THE REPORTER HAS SCLERODERMA DISEASE ( A DISEASE IN WHICH THE SKIN BECOMES PROGRESSIVELY HARD AND THICKENED). SHE MET WITH ONE DR (B)(6), WHO RECOMMENDS A NARROW BAND UV LIGHT THERAPY. DURING TREATMENT SHE WAS EXPOSED TO THE UV LIGHT, SHE NOW HAS BURNS ALL OVER HER BODY, SHE BELIEVE IS SHE STAYED UNDER THE LIGHT LONGER THAN SHE WAS SUPPOSED TO. AFTER FIVE SESSIONS OF THE TREATMENT SHE DEVELOPED SEVERE CONTRACTURE ON SKIN, UPPER AND LOWER ARMS, AND CHEST, ALSO BLISTERS ALL OVER HER ARMS. HER CONDITION GOT WORST THAN SHE WAS BEFORE THE TREATMENT. SHE WAS GIVEN A STEROID OINTMENT (TRIAMCINOLONE) AND PERCOCET FOR PAIN. SHE REFUSES TO GO BACK TO THE DOCTOR AS HE IS NOT HELPING AND SHE DOES NOT KNOW THE MANUFACTURER OF THE DEVICE.