BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTEK COMFORT-FIT DENTAL GUARD

    MDR report key: 2903479 · Received January 3, 2013

    Report

    Report Number
    2938386-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 3, 2013
    Manufacturer
    DENTEK ORAL CARE, INC.
    Product Code
    OBR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS WAS THE FIRST INCIDENT REPORTED OF THE GUARD POSSIBLY CONTRIBUTING TO GUM RECESSION WHICH REQUIRED MEDICAL INTERVENTION TO REPAIR. THE DEVICE IFU STATES "ASK A DENTIST BEFORE USE IF YOU HAVE: ORAL SORES, BLEEDING GUMS OR ANY GUM DISEASE. STOP USE AND ASK DENTIST IF: YOU DEVELOP SORENESS, BLEEDING GUMS OR ANY OTHER REACTION INSIDE YOUR MOUTH; YOU DEVELOP JAW PAIN, TEETH PAIN, EAR PAIN, HEADACHE, NECK STIFFNESS, OR JOINT CLICKING WHEN USING THIS PRODUCT; THE SAME SYMPTOMS PERSIST AFTER OVER A MONTH OF USE." IT IS OUR EXPECTATION THAT A USER WHO EXPERIENCES ANY OF THESE CONDITIONS WOULD STOP WEARING THE GUARD IMMEDIATELY AND SEEK THE ADVICE OF THEIR DENTIST AS TO HOW TO PROCEED. THE USER NEVER COMPLAINED THAT THE DEVICE DID NOT FUNCTION AS INTENDED, IN TERMS OF PROTECTING THE TEETH FROM GRINDING. THE USER REPORTED THAT NO PAIN WAS EXPERIENCED, WHICH SEEMS HIGHLY UNUSUAL. THE USER ONLY NOTICED THAT THE GUMS HAD RECEDED ONCE THE CONDITION WAS AT AN UNACCEPTABLE LEVEL. ALTHOUGH DENTEK THOUGHT THAT THE CURRENT LABEL WARNINGS WERE ADEQUATE TO WARN USERS OF POSSIBLE ADVERSE EFFECTS. OF WEARING A GUARD THAT MAY NOT FIT THEIR PHYSIOLOGY WELL, A STATEMENT HAS BEEN ADDED TO THE IFU "STOP USE AND ASK A DENTIST IF: YOU DEVELOP A CHANGE IN THE APPEARANCE OF YOUR GUMS." DENTEK HAS BEEN TRACKING COMPLAINTS OF GUM IRRITATION FOR THE PAST 2 YEARS. OUR NEW COMFORT-FIT DENTAL GUARD, K123849 CURRENTLY UNDER REVIEW, INCORPORATES DESIGN CHANGES TO IMPROVE USER COMFORT IN THIS AREAS. IFU FOR THE NEW COMFORT-FIT WILL CONTAIN THIS ADDITIONAL WARNING STATEMENT.

    Description of Event or Problem · 1

    THE USER PURCHASED A DENTEK COMFORT-FIT DENTAL GUARD AT A RETAIL STORE IN (B)(6) 2011 AND WORE IT FOR TWO TO THREE MONTHS. SHE NOTICED THAT HER GUMS HAD RECEDED ON SOME OF HER TEETH AND SHE WENT TO HER REGULAR DENTIST ON (B)(6) 2012 TO SEE IF THE GUM WOULD REPAIR ITSELF. AS STATED IN A LETTER DATED ON (B)(6) 2012, WRITTEN BY THE DENTIST TO DENTEK'S INSURANCE CARRIER, THE DENTIST OBSERVED THE GUM RECESSION AND ADVISED THE USER TO STOP WEARING THE GUARD AS HE FELT IT WAS A LIKELY FACTOR IN THE AREAS OF RECESSION. AFTER A PERIOD OF OBSERVATION, HE REFERRED THE USER TO A PERIODONTIST FOR CONSULTATION AND TREATMENT OF THE GRAFT. THE PERIODONTIST FIRST SAW THE USER ON (B)(6) 2012 AND OBSERVED 4MM OF RECESSION ON TEETH #'S 19 AND 30. AFTER THIS EVAL, A GUM GRAFT FOR BOTH EFFECTED AREAS WAS RECOMMENDED. IN A LETTER DATED (B)(6) 2012 WRITTEN TO DENTEK'S INSURANCE CARRIER, THE PERIODONTIST STATED THAT WHEN THE DENTAL GUARD WAS IN PLACE IN THE PT'S MOUTH, IT WAS OBSERVED TO CONTACT THE ROOT SURFACES OF THE #'S 19 AND 30 WHERE THE GUM RECESSION WAS PRESENT. AFTER VISITING THE PERIODONTIST AND UNDERSTANDING THAT A SURGICAL INTERVENTION WAS NECESSARY TO REPAIR THE GUM RECESSION, THE USER CONTACTED DENTEK'S CUSTOMER CALL CENTER ON (B)(6) 2012. DENTEK LOGGED A FORMAL COMPLAINT IN OUR SYSTEM AND CONDUCTED A MEDICAL DEVICE REPORT DETERMINATION. AS WE HAD NO SUBSTANTIAL EVIDENCE, PRIOR EXPERIENCE OF THIS TYPE OF EVENT, OR CONFIRMATION FROM THE PROFESSIONALS INVOLVED THAT OUR DENTAL GUARD MAY HAVE CONTRIBUTED TO THE GUM RECESSION, DENTEK DID NOT FILE A MEDWATCH REPORT AT THIS TIME. INSTEAD, WE REQUESTED WRITTEN COMMENTS FROM THE TREATING PROFESSIONALS THROUGH OUR INSURANCE AGENCY WHICH HANDLED THE CLAIM, AND PUT THE REPORT ON HOLD. THE USER RECEIVED A GUM GRAFT TO TOOTH #19 ON (B)(6) 2012 AND TO TOOTH #30 ON (B)(6) 2012. THE USER FILED PAPERWORK WITH DENTEK AFTER THE TREATMENT WAS COMPLETED, WHICH DENTEK SUBMITTED TO OUR INSURANCE AGENCY. THE CLAIM WAS FINALLY PAID AFTER RECEIPT OF LETTERS FROM THE DENTIST, DATED (B)(6) 2012, AND FROM THE PERIODONTIST DATED (B)(6) 2012, SUGGESTING THAT THE DENTEK DENTAL GUARD COULD HAVE CONTRIBUTED TO THE GUM RECESSION, AS REFERRED TO ABOVE. DENTEK WAS NOTIFIED THAT THESE LETTERS FROM THE TREATING PROFESSIONALS HAD BEEN RECEIVED, VIA AN E-MAIL TO OUR CONTROLLER FROM OUR INSURANCE CARRIER ON (B)(6) 2012 INDICATING THE CLAIM HAD BEEN PAID BASED ON THE LETTERS AND THE CASE WAS CLOSED. AT THAT POINT DENTEK BEGAN THE PROCESS OF COMPLETING THIS MEDWATCH REPORT, AND DATED THE EVENT AS (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3230 DENTEK COMFORT-FIT DENTAL GUARD DENTAL GUARD; PRODUCT CODE: OBR OBR DENTEK ORAL CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention