FDA.reportPublic FDA data

MAUDE MDR 21918

MDR report key
21918
Report number
21918
Event key
0
Event type
3
Date of event
1995-04-24
Date received
1995-05-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHOTOTHERAPY CHAMBERULTRA VIOLET CHAMBERULTRALITE ENTERPRISES, INC.KGLV4472-IVUNKNOWNNANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-05-0101. O

Event Narratives#

D

Patient 1

ULTRAVIOLET THERAPY CHAMBER WAS CLEANED BY A MAINTENANCE TECHNICIAN. ULTRAVIOLET A & B WAVE BULBS WERE REMOVED FOR CLEANING. WHEN BULBS WERE REPLACED THEY WERE NOT PUT IN THE CORRECT SLOTS THUS PTS WERE SUBJECTED TO INCORRECT PHOTOTHERAPY DOSAGES. FOUR PTS WERE GIVEN THERAPY BEFORE THE BULB MIXUP WAS DISCOVERED. THEY ALL RECEIVED 1ST DEGREE BURNS. THERE IS NO WARNING ON THE BULBS OR CHAMBER ADDRESSING THE POSSIBILITY OF BULB MIXUP. THERE ARE ONLY SMALL RED DOTS ABOVE THE RED SLOTS.