MAUDE MDR 551403

MDR report key
551403
Report number
551403
Event key
0
Event type
3
Date of event
2002-02-22
Date received
2002-11-05
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
1*PHOTOTHERAPY CABINETULTRALITE ENTERPRISES, INC.KGLV4848NBDO NOT KNOWDO NOT KNOWNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-11-050

Event Narratives#

D

Patient 1

THIS IS A PT WITH A HISTORY OF PSORIASIS THAT WAS NOT RESPONSIVE TO ORAL OR TOPICAL MEDICATIONS. THEY ARE A SKIN TYPE II. THEY WERE SEEN IN THE DERMATOLOGY CLINIC IN 2002 WHERE THE DECISION WAS MADE TO BEGIN LOW DOSE NARROW BAND UVB ULTRAVIOLET BBECAUSE PREVIOUS BROAD BAND APPLICATIONS HAD BEEN MINIMALLY SUCCESSFUL. THE MD CALCULATED THE DOSE TO BE 0.13 JOULES. THE NORMAL RANGE IS 0.1 TO 2.0. THE ORDER WAS WRITTEN AS 1.3 JOULES. THE NURSE ADMINISTERED THE ORDERED AMOUNT. THE PATIENT CALLED THE NEXT DAY TO REPORT A SUNBURN WITH NO BLISTERING FIRST DEGREE BURN. THIS WAS A NEW MACHINE, AND THE NURSE FELT THEY HAD NOT RECEIVED ADEQUATE INSTRUCTION ON HOW TO USE IT. USE OF THE MACHINE WAS DISCONTINUED UNTIL THE PROPER EDUCATION WAS GIVEN AND COMPETENCY HAD BEEN DEMONSTRATED BY THE STAFF. THE MANUFACTURER DOES NOT PROVIDE DOSING OR USE RANGE GUIDELINES IN THEIR MANUAL. THE MANUFACTURER DID NOT PROVIDE TRAINING. THERE IS DEPARTMENTAL TRAINING AND THE FACILITY HAS DEVELOPED A DEPARTMENTAL PROTOCOL FOR THIS DEVICE. NURSES AND ASSISTANTS ARE SENT TO THE NATIONAL PSORIASIS PHOTOTHERAPY COURSE. THE DEVICE WAS NOT USED AGAIN ON THIS PATIENT. THE PATIENT WAS SEEN IN FOLLOW UP CONSULTATION. THE PATIENT SUBSEQUENTLY HAD ONE TREATMENT USING THE BROADBAND UVB UNIT. THE ULTRALITE NARROW WAVE BAND DEVICE IS BEING USED FOR OTHER PATIENTS UNDER A PROTOCOL WRITTEN BY THE DEPARTMENT. PRIOR TO THE EVENT, THE DEPARTMENT HAD INSTITUTED A PROTOCOL TO DOUBLE-CHECK DOSE CALCULATION AND TRANSCRIPTION PRIOR TO THE ADMINISTRATION OF THERAPY.