VELSCOPE NOT KNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-25 for VELSCOPE NOT KNOWN manufactured by Led Dental Inc.

Event Text Entries

[825004] My dentist just started using the velscope this past year. I have had two examinations with the device during my routine teeth cleanings. Each time following the exam my mouth felt "funny" afterwards and my taste buds seemed to be "off", much like the after feeling following accidental scald on your tongue with a hot liquid, not the initial burn feeling. This effect continues for a few days following the examination, slowly turning back to normal. Being an engineer i was curious about the wavelength being employed by the velscope. I have been to the velscope website but there was not much technical info there, and the only contact appears to be with the sales dept. The website only refers to the light as being "safe blue" which means very little. My experience with fluorescence in my research work makes me wonder if the light being used includes some uv wavelengths as well. If this is the case, then the sensation i am feeling in my mouth could be a slight "sun burn" of the tissue. My concern is that inner mouth tissue is not normally exposed to intense uv, and that this examination technique used twice a year over many years may result in an increased mouth cancer risk. All associated products used during the teeth cleaning were things that have been used previously without the velscope, and did not affect my mouth in the manner being described here. Dose or amount: exposure of one minute or less, frequency: twice a year, route: dental. Dates of use: 2007- 2008. Diagnosis or reason for use: oral exam, screening for cancer. Event abated after use stopped or dose reduced? Yes. Event reappeared after reintroduction? Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006044
MDR Report Key1020016
Date Received2008-03-25
Date of Report2008-03-25
Date of Event2008-03-04
Date Added to Maude2008-07-18
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVELSCOPE
Generic NameORAL CANCER SCREENING SYSTEM
Product CodeNXV
Date Received2008-03-25
Model NumberNOT KNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key989055
ManufacturerLED DENTAL INC
Manufacturer Address201-15047 MARINE DR WHITE ROCK BC CA V4B 1C5


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-03-25

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