MI VARNISH
Received May 2, 2013 · Event occurred Apr 15, 2013
Report 1410097-2013-00001 · MDR key 3113569
Device
Product problems
- No Apparent Adverse Event
Patient
Not reported
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
DR. REPORTED ALLERGIC REACTION TO PRODUCT. DURING MEDICAL HISTORY IT WAS NOTED THAT PT HAD FOOD ALLERGIES TO NUTS AND SEAFOOD. OTHER ALLERGIES REVIEWED RELATED TO THE PRODUCT ARE MILK ALLERGY, PINE TREE EXTRACT ROSIN AND PRESERVATIVES. PT'S MOTHER GAVE PERMISSION TO THE HEALTHCARE PROFESSIONAL TO USE THE PRODUCT. PT WAS THEN GIVEN A VARNISH TREATMENT AND SOON STARTED TO COMPLAIN THAT HER THROAT WAS CLOSING UP. PT'S MOTHER HAD AN EPI PEN AND IMMEDIATELY DISPENSED IT TO THE PT. ADVERSE REACTION SUBSIDED. CONTINUED CONTACT WITH DENTAL OFFICE YIELDED NO FURTHER MEDICAL INTERVENTION WAS NEEDED.
Additional Manufacturer Narrative
CUSTOMER SVC INTERVIEWED HEALTHCARE PROFESSIONAL. PT HAD AUTHORIZED USE OF MEDICAL DEVICE.