DENTEK FRESH CLEAN FLOSS PICKS, LONG LASTING MINT

Description of Event or Problem

INITIAL (B)(6) 2025): THIS SERIOUS CASE REPORTED VIA EMAIL REFERS TO A FEMALE CONSUMER WHOSE AGE, UNDERLYING CONDITIONS, CONCOMITANT MEDICATIONS, AND ALLERGIES WERE NOT REPORTED. THE CONSUMER USED DENTEK FRESH CLEAN FLOSS PICKS FOR FLOSSING AND EXPERIENCED GUM PAIN, GUM BLEEDING, AND TOOTH PAIN. SHE PRESENTED TO THE DENTIST WHERE THEY DRILLED OUT PART OF A FILLING AND FOUND A SMALL PIECE OF GREEN PLASTIC FROM THE PICKS WAS FOUND LODGED INTO THE GUM. THIS CASE OUTCOME IS RECOVERED/RESOLVED. MEDDRA VERSION 28.1. EXPECTEDNESS: TOOTHACHE: UNEXPECTED. GINGIVAL PAIN: UNEXPECTED. FOREIGN BODY IN MOUTH: UNEXPECTED. GINGIVAL BLEEDING: UNEXPECTED. DEVICE BREAKAGE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION

Description of Event or Problem

INITIAL (26-NOV-2025): THIS SERIOUS CASE REPORTED VIA EMAIL REFERS TO A FEMALE CONSUMER WHOSE AGE, UNDERLYING CONDITIONS, CONCOMITANT MEDICATIONS, AND ALLERGIES WERE NOT REPORTED. THE CONSUMER USED DENTEK FRESH CLEAN FLOSS PICKS FOR FLOSSING AND EXPERIENCED GUM PAIN, GUM BLEEDING, AND TOOTH PAIN. SHE PRESENTED TO THE DENTIST WHERE THEY DRILLED OUT PART OF A FILLING AND FOUND A SMALL PIECE OF GREEN PLASTIC FROM THE PICKS WAS FOUND LODGED INTO THE GUM. THIS CASE OUTCOME IS RECOVERED/RESOLVED. MEDDRA VERSION 28.1. EXPECTEDNESS: TOOTHACHE: UNEXPECTED. GINGIVAL PAIN: UNEXPECTED. FOREIGN BODY IN MOUTH: UNEXPECTED. GINGIVAL BLEEDING: UNEXPECTED. DEVICE BREAKAGE . ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION. FOLLOW UP (29-DEC-2025): THE CONSUMER PROVIDED MEDICAL RECORDS FROM HER VISIT TO THE DENTIST. THE RECORDS INDICATE THAT PATIENT WAS EXPERIENCING PAIN AND BLEEDING IN THE GUMS AND THE DENTIST SUGGESTED THAT THERE WAS OPEN CONTACT BETWEEN TWO TEETH WHICH CAN CAUSE FOOD TO GET STUCK AND CAUSE IRRITATION, HE RECOMMENDED HAVING A FILLING DONE TO CLOSE THE CONTACT BETWEEN TWO TEETH. DURING PREPARATION FOR THE FILLING THE DENTIST REMOVED A "SMALL GREEN PLASTIC OBJECT THAT LOOKED TO BE THE END OF A FLOSSER." THE CASE WAS UPDATED TO MEDICALLY CONFIRMED, NO ADDITIONAL TERMS WERE ADDED. THE INVESTIGATION IS NOW COMPLETE AND IMDRF CODES HAVE BEEN UPDATED.