inforMED
InjuryNXV

VELSCOPE

Received Mar 25, 2008 · Event occurred Mar 4, 2008

Report MW5006044 · MDR key 1020016

Device

Generic name

Oral Cancer Screening System

Manufacturer

Led Dental Inc

Model number

NOT KNOWN

Product problems

  • Labelling, Instructions for Use or Training Problem

Patient

41 YR

  • Complaint, Ill-Defined

Narrative

Description of Event or Problem

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.