FDA Adverse Event Other Summary report: N

SUPER POLIGRIP

MDR report key: 522205 · Received April 23, 2004

Report

Report Number
9681138-2004-00004
Event Type
Other
Date Received
April 23, 2004
Date of Event
February 27, 2004
Report Date
April 21, 2004
Manufacturer
GLAXOSMITHKLINE CONSUMER HEALTHCARE MED AFFAIRS, US PROD SAFETY
Product Code
KOP
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CONSUMER REPORTED HAVING EXPERIENCED A LOSS OF CONSCIOUSNESS DURING AN EPISODE OF SEVERE DIARRHEA WHILE USING SUPER POLIGRIP DENTAL ADHESIVE. THE CONSUMER FURTHER REPORTED THAT THEY HAVE HAD 12 SIMILAR EPISODES OF A BRIEF LOSS OF CONSCIOUSNESS DURING BOUTS OF SEVERE DIARRHEA SINCE THEY WERE YOUNGER. THE CONSUMER WHO HAD NEVER DISCUSSED THESE EPISODES WITH THEIR PHYSICIAN OR SOUGHT MEDICAL ATTENTION FOR THESE EVENTS, DECLINED TO REPORT SPECIFIC DETAILS ABOUT THEIR PAST ESPIODES. THE CONSUMER CONTACTED THE MFR TO REPORT THEIR EXPERIENCE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. IN 2004, THE CONSUMER BEGAN THE USE OF SUPER POLIGRIP DAILY. THE FOLLOWING DAY THE CONSUMER EXPERIENCED STOMACH CRAMPS WITH LOOSE STOOLS THAT CONTINUED UNTIL 3 DAYS LATER. ONE DAY AGO THE CONSUMER TOOK PEPTOBISMOL TO HELP RELIEVE THEIR SYMPTOMS OF DIARRHEA BUT THEY REPORTED THAT IT HAD NOT HELPED. THE CONSUMER FURTHER REPORTED THAT THEY HAD SUPER POLIGRIP IN PLACE FOR TWENTY FOUR HOURS, BECAUSE THEY HAD NOT RINSED THEIR MOUTH OR REMOVED THEIR DENTURES BEFORE SLEEP. ON THE MORNING OF THE FOLLOWING DAY, THE CONSUMER AWOKE FROM SLEEP WITH SEVERE STOMACH CRAMPS AND SEVERAL EPISODES OF SEVERE, WATERY, DIARRHEA THAT CAME IN FIVE-MINUTE WAVES AND LASTED FOR ABOUT A HALF-HOUR. THE CONSUMER REPORTED THAT THEY BECAME LIGHTHEADED, HAD CHILLS AND HAD A LOSS OF CONSCIOUSNESS WHILE ON THE TOILET DURING THEIR LAST WAVE OF WATERY DIARRHEA. THEY REPORTED THAT THEY AWOKE UP ABOUT A MINUTE ON THE FLOOR NEXT TO THE TOILET AND THEY COULD NOT RECALL HOW THEY GOT THERE. THE CONSUMER REPORTED THAT THEY THEN BEGAN FEELING VERY WEAK, VOMITED AND THEN WENT TO REST IN BED. THE CONSUMER WAS ALONE DURING THE EVENT AND THEY DID NOT CALL FOR HELP FROM SPOUSE WHO WAS IN ANOTHER PART OF THE HOME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUPER POLIGRIP DENTURE ADHESIVE KOP GLAXOSMITHKLINE CONSUMER HEALTHCARE MED AFFAIRS, US PROD SAFETY * R03211

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other 1. NAPROXEN SODIUM, UNK.