Description of Event or Problem · 0
DEAR U.S. FOOD AND DRUG ADMINISTRATION, I WOULD LIKE TO REPORT A DENTAL APPLIANCE, (B)(6) COMFORT DENTAL GUARD U.S. AS DEFECTIVE AND DANGEROUS. I HAVE RETAINED THE ORIGINAL PACKAGING AND COMFORT GUARD, (IT'S A NIGHT GUARD TO PREVENT THE GRINDING OF TEETH), AND PURCHASE RECEIPT AS EVIDENCE. IN ADDITION, CVS AND THE MAKER OF THE COMFORT GUARD HAS DELIBERATELY BEEN UNRESPONSIVE AND NON-COMPLIANT OVER A PERIOD OF OVER TWO YEARS. AT THE RECOMMENDATION OF MY PERIODONTIST, (B)(6), I PURCHASED A CVS HEALTH COMFORT DENTAL GUARD (SKU#902457) FROM THE MOUNT LOOKOUT CVS HEALTH STORE ON (B)(6) 2021. I FOLLOWED THE DIRECTIONS CAREFULLY TO MAKE THE IMPRINT IN THE DENTAL GUARD TO WEAR AS A NIGHT TIME RETAINER. I WORE THE MEDICAL DEVICE FOR 10 NIGHTS AND I NOTICED THAT IT HAD PUSHED MY TWO TOP FRONT TEETH IN AND ALSO MOVED THE TWO SURROUNDING TEETH. PRIOR TO WEARING THE DEVICE, MY TEETH WERE PERFECTLY STRAIGHT AND I HAVE PICTURES AND MOLDS TO PROVE IT. THE (B)(6) DENTAL GUARD WAS TOO SMALL FOR MY BITE SIZE, EVEN THOUGH ON THE BOX IT SAYS ONE SIZE FITS ALL. THE DAMAGE TO MY TEETH FROM THE CVS COMFORT GUARD ALSO CAUSED A LISP IN MY SPEECH. I HAVE HAD TO SPEND THOUSANDS OF DOLLARS OVER THREE YEARS AT MY ORTHODONTIST IN ORDER TO CORRECT MY BITE, BUT I STILL HAVE TO WEAR A METAL BAR BEHIND MY TEETH AND CANNOT FLOSS OR BRUSH MY TEETH THE SAME FOR THE REST OF MY LIFE. I REACHED OUT TO THE (B)(6) CLAIMS DEPARTMENT CUSTOMER SERVICE DEPARTMENT 15 TIMES FROM (B)(6) 2022 THROUGH (B)(6) 2023 AND GOT REFERRED FIRST TO (B)(6) AND THEN (B)(6). THEY WERE VERY UNRESPONSIVE. I CALLED AND EMAILED THEM 8 TIMES WITHOUT A RESPONSE OVER A PERIOD OF SEVERAL MONTHS - THEY DID NOT ANSWER THEIR PHONE EITHER. I FILED A CLAIM WITH PRESTIGE CONSUMER HEALTHCARE ON (B)(6) 2023, FOR WHICH THERE WAS NO RESPONSE FOR MONTHS, AND THEN THEY DENIED IT. IN THE CLAIM, I PROVIDED PICTURES OF MY DENTAL MOLDS, PICTURES OF MY TEETH, A PICTURE OF THE (B)(6) COMFORT GUARD THAT I WORE, A LETTER FROM MY PERIODONTIST - ALL THE EVIDENCE THEY REQUESTED - AND THEY DENIED MY CLAIM. I THEN FILED AN APPEAL, AND THEY DID NOT FOLLOW THE CORRECT APPEAL PROCESS AND INSTEAD TREATED IT AS THE SAME CLAIM AND DENIED IT. WHAT THEY ARE DOING IS BEING UNRESPONSIVE AND DISMISSIVE OF THEIR RESPONSIBILITY FOR THIS PRODUCT. THEY DELIBERATELY DO NOT PROVIDE SUPERVISOR OR MANAGER NAMES WHEN ASKED - THEY REFUSE TO GIVE THIS INFORMATION. IN SUMMARY, THIS PRODUCT IS DEFECTIVE AND NEEDS TO BE REMOVED FROM THE STORES SO THAT NO ONE ELSE IS HARMED BY THIS PRODUCT. IT RUINED MY TEETH AND HAS CAUSED ME YEARS OF GRIEF AND THE WHOLE TIME, BOTH (B)(6) CONSUMER HEALTHCARE, DISTRICT LEADER, (B)(6) HEALTH STORES, AND (B)(6) AT (B)(6) MANAGEMENT SERVICE HAVE ALL BEEN DELIBERATELY UNRESPONSIVE AND NON-COMPLIANT WITH THE CONSUMER CLAIMS PROCESS. THIS IS ILLEGAL. PLEASE RESPOND AT YOUR EARLIEST CONVENIENCE IF MORE INFORMATION IS REQUIRED FOR YOU TO PROCEED. THANK YOU. (B)(6).