MAUDE MDR 468600

MDR report key
468600
Report number
468600
Event key
0
Event type
3
Date of event
2003-05-23
Date received
2003-06-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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-MINIULTRAVIOLET - A LIGHT BOXDAAVLIN COIOBH-F UVA - HO**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-06-0201. H

Event Narratives#

D

Patient 1

1) BILATERAL BURNS ON SOLES OF FEET DUE TO ULTRAVIOLET-A TREATMENT THAT SHOULD HAVE BEEN 50 SEC. IN DURATION AND MAY HAVE BEEN 1 HOUR. 2) TIME WAS INCORRECTLY SET WHEN THE STAFF PERSON MOVED THE "SECOND" DIAL TO 50 SECONDS, THEN MOVED THE "MINUTE" PER COUNTER CLOCKWISE 1 NOTCH, THUS SETTING THE TIMER TO 59 MINUTES AND 50 SECONDS. 3) AT TIME OF REPORT, PT IS HOSPITALIZED AT A BURN TREATMENT FACILITY. 4) PT WAS SCHEDULED FOR PHOTOTHERAPY TREATMENT ON FEET AND HANDS IN 2003. THIS WAS PT'S SECOND TREATMENT FOR THIS MEDICAL CONDITION. THE LIGHT BOX FOR THE PT'S FEET WAS SET FOR 59 MINUTES AND 50 SECONDS INSTEAD OF THE DESIGNATED 50 SECONDS. THE LIGHT BOX FOR THE PT'S HANDS WAS SET CORRECTLY AND WITHOUT INCIDENT. REGARDING THE LIGHT BOX, THE USER INDICATED THIS IS A "TOUCHY" LIGHT BOX TO WORK WITH. MEANING IT IS DIFFICULT TO KNOW EXACTLY HOW MUCH TIME IS SET. AFTER VERIFYING THAT THE MINUTES/SECONDS WERE BOTH ON "ZERO", THE USER TURNED THE SECONDS' DIAL CLOCKWISE (AS IS PROTOCOL) TO 50 SECONDS. THE USER CHECKED THE MINUTES' PEG TO MAKE SURE IT WAS STILL ON "ZERO", SINCE IT APPEARED TO BE ON 1 MINUTE THEY MOVED THE PEG BACKWARDS (COUNTER-CLOCKWISE) TO WHAT THEY THOUGHT WAS "ZERO." IN REALITY, THEY PUT THE MINUTES' PEG ON "59 MINUTES" WITH A TOTAL TIME SETTING OF 59 MINUTES AND 50 SECONDS. THE USER THEN TURNED THE LIGHT BOX ON AND RESUMED OTHER DUTIES.