DENTEK TEMPARIN TEMPORARY REPAIR 2.64 G

Description of Event or Problem

INITIAL (09-MAY-2025): THIS SERIOUS CASE REPORTED VIA BAZAARVOICE REFERS TO A CONSUMER WHOSE GENDER, AGE, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. ON AN UNREPORTED DATE, THE CONSUMER USED DENTEK TEMPARIN MAX REPAIR KIT FOR A CAVITY AND REPORTED IT MADE THE SITUATION FAR WORSE AND A TOOTH CRACKED. THIS CASE OUTCOME IS UNKNOWN. MEDDRA VERSION 27.1. EXPECTEDNESS: CONDITION AGGRAVATED: UNEXPECTED. TOOTH FRACTURE: UNEXPECTED. INTENTIONAL PRODUCT: MISUSE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.