Description of Event or Problem · 1
THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE ON (B)(6) 2013. THE CONSUMER REPORTS THAT SHE USED THE PRODUCT FOR 3 NIGHTS SEVERAL MONTHS AGO (SHE COULD NOT SPECIFY). SOME TIME DURING HER USE, SHE DEVELOPED AN OPEN SORE IN HER GUMS. SHE WAS SEEN BY A PHYSICIAN WHO PRESCRIBED ANTIBIOTIC MOUTHWASH. HER SYMPTOMS DID NOT IMPROVE SO SHE WAS REFERRED TO A PERIODONTIST, WHO PRESCRIBED AN ANTIBIOTIC FOR 7 DAYS. HER SYMPTOMS STILL PERSISTED SO SHE WAS THEN REFERRED FOR ORAL SURGERY. SHE HAD THE SURGERY DURING THE WEEK OF (B)(6) 2013. DURING THE SURGERY PART OF HER GUM-LINE AND JAW BONE WERE REMOVED AND A SMALL PIECE OF SOLID MATERIAL THAT THE SURGEON INDICATED WAS A PLASTIC-LIKE CONSISTENCY FELT TO BE FROM THE PRODUCT WAS FOUND EMBEDDED IN HER GUMS. SHE HAD HER STITCHES TAKEN OUT ON (B)(6) 2013. SHE NO LONGER HAS THE PRODUCT PACKAGING SO SHE IS UNABLE TO PROVIDE A LOT NUMBER. FOLLOW-UP INFO RECEIVED VIA PHONE ON (B)(6) 2013. THE CONSUMER REPORTS THAT HER MOUTH IS STILL CURRENTLY HEALING. SHE REPORTS THAT DURING THE SURGERY THE REMOVED A LARGE PART OF HER GUM AND PART OF HER JAW BONE. IT SEEMS TO BE HEALING WELL, BUT SHE REPORTS THAT HER MOUTH IS STILL SORE AND THE AREA FEELS STRANGE TO HER SINCE SUCH A LARGE PART OF HER GUM IS MISSING. SHE HAS BEEN USING CHLORHEXIDINE GLUCONATE MOUTHWASH TWICE DAILY, AMOXICILLIN, SHE WAS USING TYLENOL WITH CODEINE, BUT NOW IS ON IBUPROFEN FOR THE PAIN.