FDA Adverse Event Death Summary report: N

COREGA ULTRA

MDR report key: 3142891 · Received May 30, 2013

Report

Report Number
9681138-2013-00008
Event Type
Death
Date Received
May 30, 2013
Report Date
May 28, 2013
Manufacturer
GLAXOSMITHKLINE
Product Code
KOL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MX
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

THIS CASE WAS REPORTED BY A CONSUMER VIA THE "RETO COREGA" MARKETING PROGRAM AND DESCRIBED THE OCCURRENCE OF DEATH (NOS) IN A MALE PATIENT WHO USED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (ULTRA COREGA) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEATH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING ULTRA COREGA. AN UNKNOWN TIME LATER, THE PATIENT DIED FROM AN UNSPECIFIED CAUSE. IT WAS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED, AND NO PHYSICIAN CONTACT INFORMATION WAS AVAILABLE. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00008. ULTRA COREGA IS MANUFACTURED IN (B)(4), AND MARKETED AS SUPER POLIGRIP IN THE UNITED STATES. NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
238405 COREGA ULTRA DENTURE ADHESIVE POWDER - DOUBLE SALT KOL GLAXOSMITHKLINE NA

Patients

Seq Age Sex Outcome Treatment
1 Death