DENTUREID

Additional Manufacturer Narrative

ON JANUARY 23, 2019 I RECEIVED AN EMAIL FROM CUSTOMER SERVICE FORWARDING AN INQUIRY FROM THE WEBSITE. THE EMAIL WAS FROM (B)(6) OF (B)(6) DENTAL ARTS ((B)(6)) REQUESTING THAT HE SEND BACK 7 MICROCHIPS FOR REIMBURSEMENT. HE STATED THAT A PATIENT HAD A REACTION TO THE RADIO FREQUENCY OR SOMETHING IN THE DENTUREID AND HAD TO GO TO THE ER. I CONTACTED (B)(6) DENTAL ARTS AND SPOKE TO (B)(6). (B)(6) TOLD ME THAT THE DENTUREID WAS REMOVED FROM THE PATIENT APPLIANCE AND WAS NOT AVAILABLE FOR RETURN SINCE THE LAB DISPOSED OF DENTUREID. THE APPLIANCE WAS THEN RETURNED TO THE PATIENT FOR USAGE. I REQUESTED INFORMATION ON WHAT WAS USED TO FABRICATE THE APPLIANCE AND THE MATERIAL USED TO EMBED THE DENTUREID ON FEBRUARY 1, 5, 8, 18, 19 AND 28, 2019. I DID NOT GET A DEFINITIVE ANSWER AT THIS TIME. I REQUESTED PATIENT INFORMATION AND WHAT MATERIALS WERE USED TO FABRICATE THE DENTAL APPLIANCE THAT WERE ALSO USED WITH THE DENTUREID MICROCHIP. AT THIS TIME, (B)(6) HAS NOT RETURNED MY REQUEST FOR INFORMATION. RECEIVED PRODUCTION ACCOUNT ON 4/4/19.

Description of Event or Problem

DENTAL LAB REPORTED THAT A PATIENT HAD A REACTION TO DENTUREID AND HAD TO GO THE ER.