VIRULITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for VIRULITE manufactured by Virulite Llc.

Event Text Entries

[143400642] I used the virulite device as instructed on my upper lip twice on (b)(6) 2019 at about 9am and 7pm. I woke the next day with severe burn from the bottom of my nose to the top of my lip. My cold sore had spread across my top lip and to my bottom lip. The burn extended into my right nostril. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086121
MDR Report Key8546304
Date Received2019-04-23
Date of Report2019-04-21
Date of Event2019-04-17
Date Added to Maude2019-04-24
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 NameVIRULITE
Generic NameLIGHT BASED TREATMENT FOR COLD SORES HERPES SIMPLEX VIRUS-1
Product CodeOKJ
Date Received2019-04-23
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerVIRULITE LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-23

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