UV PHOTOTHERAPY DEVICE BU-10 NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-06 for UV PHOTOTHERAPY DEVICE BU-10 NONE manufactured by Blue Scitech Co., Ltd..

MAUDE Entry Details

Report NumberMW5088849
MDR Report Key8869140
Date Received2019-08-06
Date of Report2019-08-05
Date of Event2019-08-05
Date Added to Maude2019-08-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUV PHOTOTHERAPY DEVICE
Generic NameLIGHT, ULTRAVIOLET, DERMATOLOGICAL
Product CodeFTC
Date Received2019-08-06
Model NumberBU-10
Catalog NumberNONE
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBLUE SCITECH CO., LTD.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-06

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