LIGHT, ULTRAVIOLET, DERMATOLOGICAL 822801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-28 for LIGHT, ULTRAVIOLET, DERMATOLOGICAL 822801 manufactured by Dusa Pharmaceuticals.

Event Text Entries

[4441747] Complainant reported experience after receiving a dermatology treatment to remove a cancerous spot on his face. Complainant was treated with a device called levulan kerastick (aminolevulinic acid hci) for topical solution, 20%. The cancerous spot was removed then treated with this device. Per complainant, acid was applied to his face and left on for 1 hour. Face was then treated with a blue light and an eye protector. Which complainant stated did not fit properly. Complainant stayed under the blue light lamp for 16 minutes. Since treatment, he has experienced blurry eyes. His doctor advised him that symptom would be temporary and should clear up after two weeks. It has been longer than two weeks and symptom has not improved. Complainant believes symptom was caused by the eye protection not fitting correctly during the procedure and/or acid got into his eyes. Either speculation, complainant reports ongoing issues with blurry eyes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5035886
• MDR Report Key: 3788367
• Date Received: 2014-04-28
• Date of Report: 2014-04-25
• Date of Event: 2014-03-19
• Date Added to Maude: 2014-05-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Generic Name: ULTRAVIOLET LIGHT
• Product Code: MVF
• Date Received: 2014-04-28
• Model Number: 822801
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DUSA PHARMACEUTICALS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-28