Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A CONSUMER (DAUGHTER OF PATIENT) AND DESCRIBED THE OCCURRENCE OF DEATH, UNKNOWN CAUSE IN (B)(6) YEAR-OLD FEMALE PATIENT WHO REC'D GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA DENTURE ADHESIVE CREAM) CREAM FOR DENTAL PROSTHESIS ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. CASE REPORTED BY DISTRIBUTOR TO GSK (B)(4). THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2014-00013. COREGA (DISTRIBUTED AS SUPER POLIGRIP IN THE UNITED STATES) IS MANUFACTURED IN (B)(4). WHILE THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).