SUPER POLIGRIP COMFORT SEAL STRIPS
Received Oct 16, 2020
Report 3004699328-2020-00008 · MDR key 10689238
Device
Generic name
Denture Adhesive
Lot number
20K0103
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
ARGUS CASE: (B)(4).
Description of Event or Problem
"IT'S OBSTRUCTING MY THROAT. [UPPER AIRWAY OBSTRUCTION]. IT'S NOT REALLY COMFORTABLE. IT'S SO GOOEY [ORAL DISCOMFORT]. I KEEP COUGHING, AND IT'S A REALLY DRY COUGH; IT'S NASTY. [DRY COUGH]." CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE, AND DESCRIBED THE OCCURRENCE OF UPPER AIRWAY OBSTRUCTION IN A FEMALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP (BATCH NUMBER 20K0103, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP COMFORT SEAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP COMFORT SEAL STRIPS, THE PATIENT EXPERIENCED UPPER AIRWAY OBSTRUCTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT), ORAL DISCOMFORT, AND DRY COUGH. THE ACTION TAKEN WITH SUPER POLIGRIP COMFORT SEAL STRIPS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE UPPER AIRWAY OBSTRUCTION, AND ORAL DISCOMFORT WERE UNKNOWN, AND THE OUTCOME OF THE DRY COUGH WAS NOT RECOVERED/NOT RESOLVED. THE REPORTER CONSIDERED THE UPPER AIRWAY OBSTRUCTION, AND ORAL DISCOMFORT TO BE RELATED TO SUPER POLIGRIP COMFORT SEAL STRIPS. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DRY COUGH TO BE RELATED TO SUPER POLIGRIP COMFORT SEAL STRIPS. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION, OR LIABILITY FOR THE INCIDENT, OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION RECEIVED VIA CALL CENTER REPRESENTATIVE ON 22 SEPTEMBER 2020. THE CONSUMER REPORTED, "THE FIRST TIME I TRIED THE POLIGRIP ADHESIVE STRIPS. I NEVER TRIED THIS BEFORE. I WAS USING THE DENTURE PASTE. IT'S WORSE THAN THE PASTE. THE STRIP MELTS. IT'S NOT REALLY COMFORTABLE. IT'S SO GOOEY. I LIKE THE PASTE BETTER. IT'S A LOT OF MONEY. IF YOU WOULD LIKE TO REFUND ME THAT'S OK. I CAN SEND IT BACK. IT'S NOT LIKE SEA-BOND. IT'S OBSTRUCTING MY THROAT. WHEN IT DISSOLVED I DIDN'T KNOW IT WAS SUPPOSED TO DISSOLVE. IT'S SO STICKY. I KEEP COUGHING AND IT'S A REALLY DRY COUGH AND IT'S NASTY." CONCOMITANT DRUG INCLUDED UNKNOWN DENTURE PASTE, SEA BOND.