BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP CUSHION COMFORT

    MDR report key: 10430548 · Received August 20, 2020

    Report

    Report Number
    3003341442-2020-00023
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE (B)(4).

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A 55-YEAR-OLD FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP CUSHION COMFORT) CREAM (BATCH NUMBER 083100, EXPIRY DATE 23RD FEBRUARY 2023) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)) AND NO THERAPY. ON (B)(6) 2020, THE PATIENT STARTED POLIGRIP CUSHION COMFORT. ON (B)(6) 2020, LESS THAN A DAY AFTER STARTING POLIGRIP CUSHION COMFORT AND AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIGRIP CUSHION COMFORT WAS UNKNOWN. ON (B)(6) 2020, THE OUTCOME OF THE CHOKING WAS RECOVERING/RESOLVING. ON AN UNKNOWN DATE, THE OUTCOME OF THE WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS TO BE RELATED TO POLIGRIP CUSHION COMFORT. 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 WAS RECEIVED VIA CALL CENTER REPRESENTATIVE (PHONE) ON (B)(6) 2020. CONSUMER CALLED IN ABOUT POLIGRIP CUSHION COMFORT AND REPORTED THAT, "POLIGRIP CUSHION AND COMFORT. I HAD BEEN USING THE POLIGRIP SUPER STRONG ALL DAY HOLD FREE GRIP FOR OVER 15 YEARS. I WENT TO AND THEY WERE OUT OF IT AND I BOUGHT THE POLIGRIP CUSHION AND COMFORT. MY DENTURES WERE FLOATING ALL OVER THE PLACE, I COULD NOT EAT ANYTHING AND I WAS ALSO CHOKING. IT NEVER GOT HARD. I WENT I WASHED MY MOUTH OUT WITH WATER AND BAKING SODA. I WAS DEVASTATED WITH THIS NEW PRODUCT. I COULD EAT PEANUTS AND APPLES AND EVERYTHING I WANTED AND GO ANYWHERE WITH THE ORIGINAL PRODUCT. THIS PRODUCT WAS LIKE I HAD THE BLOB IN MY MOUTH. I HAD TO STOP AT A STORE AND GET A SMALL TUBE OF THE POLIGRIP. IT DID NOT EVEN GET HARD IN MY MOUTH. LOT WAS 083100 AND EXPIRY DATE WAS 23 FEBRUARY 2023 2.2 OZ, 62 GRAM. I HAD TO RELEASE MY DENTURES AND I COULD NOT EVEN PUT MY TEETH BACK IN. THE CUSHION AND COMFORT WAS LIKE A BLOB IN MY MOUTH. I WANTED TO REPORT THIS FOR SOMEONE." CASE CORRECTED AS PER INFORMATION RECEIVED ON (B)(6) 2020. THE OUTCOME OF THE EVENT CHOKING WAS UPDATED FROM RECOVERING RESOLVING TO RECOVERED RESOLVED. FOLLOW UP INFORMATION WAS RECEIVED ON 10 SEPTEMBER 2020 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT (B)(4), FOR LOT NUMBER 083100. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT SAMPLE RECEIVED AT INVESTIGATION SITE. BASED ON THE INVESTIGATION AND THE RETURNED SAMPLE EVALUATION PERFORMED BY THE SITE, THE COMPLAINT WAS FOUND TO BE UNSUBSTANTIATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MY DENTURES WERE FLOATING ALL OVER THE PLACE, I COULD NOT EAT ANYTHING AND I WAS ALSO CHOKING. [CHOKING]. I WENT I WASHED MY MOUTH OUT WITH WATER AND BAKING SODA [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP CUSHION COMFORT) CREAM (BATCH NUMBER 083100, EXPIRY DATE 23RD FEBRUARY 2023) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)) AND NO THERAPY. ON 13TH AUGUST 2020, THE PATIENT STARTED POLIGRIP CUSHION COMFORT. ON 13TH AUGUST 2020, LESS THAN A DAY AFTER STARTING POLIGRIP CUSHION COMFORT AND AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIGRIP CUSHION COMFORT WAS UNKNOWN. ON 13TH AUGUST 2020, THE OUTCOME OF THE CHOKING WAS RECOVERING/RESOLVING. ON AN UNKNOWN DATE, THE OUTCOME OF THE WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS TO BE RELATED TO POLIGRIP CUSHION COMFORT. 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 WAS RECEIVED VIA CALL CENTER REPRESENTATIVE (PHONE) ON 13 AUGUST 2020. CONSUMER CALLED IN ABOUT POLIGRIP CUSHION COMFORT AND REPORTED THAT, "POLIGRIP CUSHION AND COMFORT. I HAD BEEN USING THE POLIGRIP SUPER STRONG ALL DAY HOLD FREE GRIP FOR OVER 15 YEARS. I WENT TO AND THEY WERE OUT OF IT AND I BOUGHT THE POLIGRIP CUSHION AND COMFORT. MY DENTURES WERE FLOATING ALL OVER THE PLACE, I COULD NOT EAT ANYTHING AND I WAS ALSO CHOKING. IT NEVER GOT HARD. I WENT I WASHED MY MOUTH OUT WITH WATER AND BAKING SODA. I WAS DEVASTATED WITH THIS NEW PRODUCT. I COULD EAT PEANUTS AND APPLES AND EVERYTHING I WANTED AND GO ANYWHERE WITH THE ORIGINAL PRODUCT. THIS PRODUCT WAS LIKE I HAD THE BLOB IN MY MOUTH. I HAD TO STOP AT A STORE AND GET A SMALL TUBE OF THE POLIGRIP. IT DID NOT EVEN GET HARD IN MY MOUTH. LOT WAS 083100 AND EXPIRY DATE WAS 23 FEBRUARY 2023 2.2 OZ, 62 GRAM. I HAD TO RELEASE MY DENTURES AND I COULD NOT EVEN PUT MY TEETH BACK IN. THE CUSHION AND COMFORT WAS LIKE A BLOB IN MY MOUTH. I WANTED TO REPORT THIS FOR SOMEONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895753 POLIGRIP CUSHION COMFORT DENTURE ADHESIVE KOT ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH 083100

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 1) SUPER POLIGRIP CREAM| 2) NO THERAPY (NO THERAPY) UNKNOWN