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MAUDE MDR 97548

MDR report key
97548
Report number
97548
Event key
0
Event type
3
Date of event
1993-12-09
Date received
1994-08-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1SPECTRA 305ULTRAVIOLET TOOTHDAAVLINIOBSPECTRA 305**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-08-0201. R

Event Narratives#

D

Patient 1

PT ENTERED UVB BOOTH WHICH WAS SET AT 400MJ (2:54). PT STARTED UVB. PTA ENTERED THE ROOM TO MONITOR TIME. AT 200 MJ (1.27) UVB HOLD BUTTON WAS PUSHED. PT WAS INSTRUCTED TO PUT PILLOW CASE OVER FACE. RESUME BUTTON WAS PUSHED AND PTA LEFT RROM. CALL LIGHT WAS PULLED BY PT. PTA ENTERED ROOM AND PT STATED, "I THINK I'VE BEEN IN HERE TO LONG!" PTA ATTEMPTED TO PUSH HOLD BUTTON SEVERAL TIMES, BUT UVB LIGHTS WOULD NOT SHUT OFF. PTA LEFT ROOM AND INSTRUCTED PT TO OPEN DOORS, AT WHICH TIME THE LIGHTS SHUT OFF. PT NOTIFIED. AFTER PT LEFT ROOM, PTA SHUT DOORS ON UVB AND LIGHTS CAME BACK ON. THE ONLY WAY LIGHTS COULD BE SHUT OFF WAS TO TURN KEY TO OFF.