* V4848NB DO NOT KNOW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-05 for * V4848NB DO NOT KNOW manufactured by Ultralite Enterprises, Inc..

Event Text Entries

[311086] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number551403
MDR Report Key551403
Date Received2002-11-05
Date of Report2002-11-05
Date of Event2002-02-22
Report Date2002-11-05
Date Reported to FDA2002-11-05
Date Added to Maude2004-10-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NamePHOTOTHERAPY CABINET
Product CodeKGL
Date Received2002-11-05
Model NumberV4848NB
Catalog NumberDO NOT KNOW
Lot NumberDO NOT KNOW
ID Number*
OperatorNURSE
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key540919
ManufacturerULTRALITE ENTERPRISES, INC.
Manufacturer Address390 FARMER COURT LAWRENCEVILLE GA 30045 US


Patients

Patient NumberTreatmentOutcomeDate
10 2002-11-05

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