POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

Report

Report Number: 1020379-2013-00003
Event Type: Other
Date Received: March 22, 2013
Report Date: March 21, 2013
Manufacturer: GLAXOSMITHKLINE
Product Code: EFT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

POLIDENT IS MANUFACTURER IN MEMPHIS, TENNESSEE, US. THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING, (B)(4).

Description of Event or Problem · 1

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANAPHYLACTIC SHOCK IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) TABLET FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED DOUBLE SALT DENTURE CLEANSER (UNKNOWN) AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER, THE PATIENT EXPERIENCED ANAPHYLACTIC SHOCK, ALLERGIC REACTION, THROAT SWELLING, ITCHY THROAT, AND HIVE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTURE CLEANSER WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CALLER REPORTED THAT SHE USED POLIDENT OVERNIGHT TABLETS AND THE BACK OF HER THROAT WAS SWOLLEN AND ITCHY. SHE REPORTED THAT SHE WAS EXPERIENCING AN ALLERGIC REACTION. SHE REPORTED IT ALMOST FELT LIKE WHEN SHE HAS ANAPHYLACTIC SHOCK WHEN SHE EATS SEAFOOD IN WHICH SHE IS ALLERGIC TO. SHE REPORTED THE EXPERIENCE WAS LIKE HAVING HIVES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
119082	POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS	DOUBLE SALT DENTURE CLEANSER	EFT	GLAXOSMITHKLINE	NA	MA1413

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Other