FDA Adverse Event Death Summary report: N

COREGA

MDR report key: 3246877 · Received July 22, 2013

Report

Report Number
9681138-2013-00022
Event Type
Death
Date Received
July 22, 2013
Report Date
July 19, 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 (SISTER OF PATIENT) AND DESCRIBED THE OCCURRENCE OF DEATH (UNKNOWN CAUSE) IN A MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) FOR DENTURES. 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). 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. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00022. COREGA (DISTRIBUTED AS SUPER POLIGRIP IN THE UNITED STATES) IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOT LOT NUMBER FOR THE PRODUCT IS AVAILABLE. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
340104 COREGA GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

Patients

Seq Age Sex Outcome Treatment
1 Death