DENTEK TEMPARIN TEMPORARY REPAIR 2.64 G

Description of Event or Problem

INITIAL ((B)(6) 2024): THIS SERIOUS CASE REPORTED VIA TELEPHONE REFERS TO A 62 YEAR-OLD MALE CONSUMER WHOSE MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. ON (B)(6) 2024 THE CONSUMER APPLIED DENTEK TEMPARIN TEMPORARY REPAIR FOR A FILLING THAT CAME OUT AND PIECES OF HIS TOOTH CAME OUT. HE ADVISED THAT HE APPLIED THE PRODUCT BEFORE BED AND WOKE UP TO FIND PIECES OF THE PRODUCT COMING OUT AS WELL AS PIECES OF HIS TOOTH. HE WENT TO THE DENTIST AND HAD THE TOOTH EXTRACTED. THE DENTAL NOTE SUGGESTS THAT THE CONSUMER PRESENTED WITH A FRACTURE IN TOOTH #31 AND A LARGE ABSCESS, THE TOOTH WAS NOT RESTORABLE. THIS CASE OUTCOME IS RECOVERED/RESOLVED. MEDDRA VERSION 261. TOOTH FRACTURE: UNEXPECTED. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.