PSORIA LIGHT PL 1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-01 for PSORIA LIGHT PL 1000 manufactured by Psoria Shield, Inc..

MAUDE Entry Details

Report NumberMW5090847
MDR Report Key9271732
Date Received2019-11-01
Date of Report2019-10-30
Date Added to Maude2019-11-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePSORIA LIGHT
Generic NameLIGHT ULTRAVIOLET, DERMATOLOGICAL
Product CodeFTC
Date Received2019-11-01
Model NumberPL 1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPSORIA SHIELD, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-01

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