DENTEK COMPLETE CLEAN FLOSS PICKS BACK TEETH, MOUTHWASH BLAST, 75 CT.

Description of Event or Problem

INITIAL (04-JUN-2024): THIS SERIOUS CASE REPORTED VIA AMAZON REFERS TO A FEMALE CONSUMER WHOSE ALLERGIES, MEDICAL HISTORY, AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER WAS USING THE PRODUCT FOR AN UNKNOWN INDICATION AND ONE OF THE PICKS BECAME DISPLACED IN BETWEEN TOOTH 14 AND 15. THE PICK REMAINED FOR OVER 6 MONTHS CAUSING DISCOMFORT AND DIFFICULTY SPEAKING AND EATING. THE PRODUCT WAS REMOVED BY A TEAM OF SPECIALIST MAXILLOFACIAL SURGEONS. THIS CASE OUTCOME IS UNKNOWN. MEDDRA VERSION 27.0 EXPECTEDNESS: ORAL DISCOMFORT: UNEXPECTED SPEECH DISORDER: UNEXPECTED MASTICATION DISORDER: UNEXPECTED COMPLICATION ASSOCIATED WITH DEVICE ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.