FDA Adverse Event Other Summary report: N

SUPER POLIGRIP ULTRA FRESH CREAM

MDR report key: 1833874 · Received September 8, 2010

Report

Report Number
9681138-2010-00314
Event Type
Other
Date Received
September 8, 2010
Report Date
September 8, 2010
Manufacturer
GLAXOSMITHKLINE
Product Code
KOL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) MALE PATIENT WHO RECEIVED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM (B)(4) ONCE DAILY FOR FOUR TO FIVE YEARS DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP (DENTAL). AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED NEUROPATHY, TIREDNESS, WEARINESS, BEDRIDDEN (DESCRIBED AS BEING ON HIS BACK MOST OF THE TIME) AND INABILITY TO WORK. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2010-00314. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). WHILE THE LOT NUMBER FOR THIS PRODUCT IS KNOWN, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUPER POLIGRIP ULTRA FRESH CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE X08481

Patients

Seq Age Sex Outcome Treatment
1 57 YR Other