LEVULAN KERASTICK WITH BLU-U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-04 for LEVULAN KERASTICK WITH BLU-U manufactured by Dusa Phamaceuticals, Inc..

Event Text Entries

[3396243] I was treated with levulan kerastick with blu-u. The treatment pain level was described as like a severe sun burn. I was treated with the chemical at 4pm the day before and had the blu-u light treatment today at 8am. I was told to stay in the light device as long as possible. After only 2 minutes, the burning was so intense i moved out of the machine. My face was burning and the pain remained at the same level. I was given an air conditioning hose which made it feel better but the relief stopped as soon as the air was turned off. I got an ice pack to take home. I waited about 45 minutes after the treatment, then drove home the sunlight was almost as bad as the light machine. I used my cowboy hat as a shield blocking the sun as well as my vision on my left side. Not a good way to drive a car. I got home and took 800 mg of ibuprofen. At 10pm after my second dose of 600 mg of ibuprofen, my face still burns. It is way more painful than any sunburn i ever had even with the ibuprofen. I understand there is a chemical medication to treat my invisible pre-cancerous sites. If i need this again i will definitely not use this treatment. The burning is similar to burns i received from time to time working in the steel industry. However, i have never had anything near the size of this burn area. I asked at least 4 times about this procedure. The first time anyone gave me an indication that there might be severe pain was the pa immediately before the treatment. Even then the degree of pain was not honestly represented. It was also not nearly enough time to make a reasonable decision. Also i believe the amount of pain is proportional to the time spent in the light machine. I was told it would be something less than 8 minutes. I used a music player and did not even make it through one song, so i knew i was well below the 8 minute figure. I probably stayed in the machine too long but i was concerned that if i did not stay longer the treatment would not be effective. I don? T like the concept of an elective preventative treatment whose time is determined by how much pain the patient can take. Dates of use: (b)(6) 2013. Reason for use: pre cancer sites on skin. Dose: 2 tubes levulan kerastick and 2 min blu-u to pre cancer sites on skin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029677
MDR Report Key3050258
Date Received2013-04-04
Date of Report2013-04-04
Date of Event2013-04-04
Date Added to Maude2013-04-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEVULAN KERASTICK WITH BLU-U
Generic NameBLUE LIGHT TREATMENT
Product CodeMVF
Date Received2013-04-04
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerDUSA PHAMACEUTICALS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-04-04

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