VIZILITE PRO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for VIZILITE PRO manufactured by Den-mat Holdings Llc.

Event Text Entries

[116714194] Hi, i went to (b)(6), for my dental appt. I got vizilite pro, oral lesion screening system to screen cancer. I am not sure if this instrument was fda/cdrh cleared / approved. Anyway, as today three days later, i still feel my tongue was burnt, not comfortable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078943
MDR Report Key7768247
Date Received2018-08-08
Date of Report2018-08-06
Date of Event2001-08-03
Date Added to Maude2018-08-09
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 NameVIZILITE PRO
Generic NameVIZILITE PRO
Product CodeNXV
Date Received2018-08-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerDEN-MAT HOLDINGS LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-08

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