BLU-U LIGHT TREATMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-19 for BLU-U LIGHT TREATMENT manufactured by Dusa Pharmaceuticals.

Event Text Entries

[20655255] Had treatment for actinic keratoses, light therapy was very painful. Six days after treatment was still having extreme pain. Redness and swelling was intense. Went back to doctor, was put on antibiotics and pain meds.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035095
MDR Report Key3695427
Date Received2014-03-19
Date of Report2014-03-18
Date of Event2014-03-11
Date Added to Maude2014-03-25
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 Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBLU-U LIGHT TREATMENT
Generic NameBLU-U LIGHT TREATMENT
Product CodeMVF
Date Received2014-03-19
Device Sequence No1
Device Event Key0
ManufacturerDUSA PHARMACEUTICALS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2014-03-19

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