BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-01 for BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR manufactured by Dusa Pharmaceuticals, Lnc, A Sun Pharma Company.

Event Text Entries

[101312407] A patient wore the orange clinical goggles instead of the patient goggles in the blu u light for full 16 minutes, 40 seconds. Now reporting welder eyes from her ophthalmologist.
Patient Sequence No: 1, Text Type: N, H10


[101312408] Welder eyes
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226354-2018-00001
MDR Report Key7307144
Report SourceHEALTH PROFESSIONAL
Date Received2018-03-01
Date of Report2018-03-01
Date Mfgr Received2018-02-06
Date Added to Maude2018-03-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25 UPTON DR
Manufacturer CityWILMINGTON MA 01887
Manufacturer CountryUS
Manufacturer Postal01887
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR
Generic NameBLU-U
Product CodeMVF
Date Received2018-03-01
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDUSA PHARMACEUTICALS, LNC, A SUN PHARMA COMPANY
Manufacturer Address25 UPTON DRIVE WILMINGTON MA 01887 US 01887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-03-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.