MI VARNISH
Received Oct 5, 2015 · Event occurred Sep 3, 2015
Report 1410097-2015-00005 · MDR key 5200530
Device
Product problems
- Improper or Incorrect Procedure or Method
- Malposition of Device
Patient
Not reported
- Burning Sensation
- Discomfort
- Sensitivity of Teeth
Narrative
Description of Event or Problem
GC AMERICA RECEIVED A REPORT FROM THE PATIENT'S HYGIENIST ON (B)(6) 2015 VIA PHONE. THE HYGIENIST REPORTED THAT PATIENT EXPERIENCED SENSITIVITY ALONG THE GUM LINE. THE HYGIENIST STATED THAT AFTER THE DISCOMFORT WENT A WAY AS SOON AS THEY RINSED THE VARNISH AWAY. THE HYGIENIST WAS ABLE TO CONFIRM THAT THE PATIENT DID NOT HAVE ANY ALLERGIES. THERE WAS NO ADDITIONAL PATIENT INJURY OR MEDICAL INTERVENTION NEEDED. PATIENT REPORTED BURNING SENSATION ON SOFT TISSUE. HYGIENIST REPORTED APPLYING A THICK LAYER OF VARNISH. THERE IS A POSSIBILITY MI VARNISH CAME IN CONTACT WITH SOFT TISSUE LEADING TO BURNING SENSATION. MI VARNISH IS TO BE APPLIED TO TOOTH ONLY.