BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP CUSHION COMFORT

    MDR report key: 10315871 · Received July 23, 2020

    Report

    Report Number
    3003341442-2020-00021
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 2, 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 Location
    OH, US
    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 39-YEAR-OLD FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP CUSHION COMFORT) CREAM (BATCH NUMBER 252449, EXPIRY DATE 24TH OCTOBER 2022) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED 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, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO POLIGRIP CUSHION COMFORT. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION 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 INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 02 JULY 2020 VIA CALL. CONSUMER STATED, "I DO NOT NORMALLY CALL AND COMPLAIN. I GOT THIS NEW KIND. IT IS A BRAND NEW ONE. THE CUSHION AND COMFORT. IT DO NOT HOLD. IT FELL OUT MY MOUTH WHEN I WAS AT WORK. I AM YOUNG. ALL THE GLUE IS STUCK ON THE TOP OF MY MOUTH I AM CHOKING I COULD NOT GET IT OUT. THIS ONE IS REALLY BAD I NEVER HAD AN ISSUE WITH ONE OF YOUR PRODUCTS. I WAS COKING AND TRYING TO SPIT IT OUT. IT WENT DOWN MY THROAT. I USED A LOT OF THE DIFFERENT KINDS OF YOUR PRODUCT AND I NEVER HAD A ISSUE. THIS IS NOT LIKE ANY GLUE I EVER HAD. IT IS HORRIBLE. IT DO NOT MAKE YOUR TEETH STICK. IT HAS BEEN HAPPENING FOR 3 DAYS. I BEEN USING IT FOR 3 DAYS. IT WILL NOT HOLD SO I HAVE TO KEEP PUTTING IT IN. BY THE TIME I AM AT WORK, IT IS COMING LOOSE. THAN I HAVE ALL THESE GLUE, I AM CHOKING ON. I AM YOUNG SO I AM ABLE TO DEAL WITH IT. BUT FOR ELDERLY PERSON THEY WILL CHOKE AND DIE. THIS IS DEFINITELY UNSAFE FOR AN ELDERLY PERSON. I JUST WANTED TO LET YOU KNOW. I DO NOT WANT ANYONE TO GET HURT. I DO NOT WANT YOU TO HAVE A LAWSUIT FROM AN OLD PERSON CHOKING AND DYING". FOLLOW UP INFORMATION WAS RECEIVED ON 21 JULY 2020 FROM THE QUALITY ASSURANCE (QA) DEPARTMENT REGARDING ISSUE (B)(4), LOT CODE 252449. QUALITY REPORT CONCLUDED THAT, PRODUCT SAMPLE NOT RECEIVED AT THE INVESTIGATION SITE. THE BATCH DOCUMENTATION OF COMPLAINT SAMPLES WAS CHECKED AND NO DEVIATIONS FOUND WHICH COULD HAVE NEGATIVE IMPACT TO THE ADHESIVE STRENGTH. NO FURTHER INVESTIGATION POSSIBLE. THEREFORE THE COMPLAINT CONSIDERED AS UNSUBSTANTIATED. THIS REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 02 JULY 2020 AND IS AS FOLLOWS: CHECKED OTHER SERIOUSNESS CRITERIA FOR EVENTS CHOKING AND ACCIDENTAL DEVICE INGESTION. FOLLOW UP INFORMATION WAS RECEIVED ON 07 AUGUST 2020 FROM THE QUALITY ASSURANCE (QA) DEPARTMENT REGARDING ISSUE (B)(4), LOT CODE 252449. QUALITY REPORT CONCLUDED THAT, PRODUCT SAMPLE NOT RECEIVED AT THE INVESTIGATION SITE. THE BATCH DOCUMENTATION OF COMPLAINT SAMPLES WAS CHECKED AND NO DEVIATIONS FOUND WHICH COULD HAVE NEGATIVE IMPACT TO THE ADHESIVE STRENGTH. NO FURTHER INVESTIGATION POSSIBLE. THEREFORE THE COMPLAINT CONSIDERED AS UNSUBSTANTIATED.

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    I AM CHOKING [CHOKING]. I WAS COKING AND TRYING TO SPIT IT OUT. IT WENT DOWN MY THROAT [ACCIDENTAL DEVICE INGESTION]. 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 252449, EXPIRY DATE 24TH OCTOBER 2022) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED 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, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO POLIGRIP CUSHION COMFORT. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIGRIP CUSHION COMFORT. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 02 JULY 2020 VIA CALL. CONSUMER STATED, "I DO NOT NORMALLY CALL AND COMPLAIN. I GOT THIS NEW KIND. IT IS A BRAND NEW ONE. THE CUSHION AND COMFORT. IT DO NOT HOLD. IT FELL OUT MY MOUTH WHEN I WAS AT WORK. I AM YOUNG. ALL THE GLUE IS STUCK ON THE TOP OF MY MOUTH I AM CHOKING I COULD NOT GET IT OUT. THIS ONE IS REALLY BAD I NEVER HAD AN ISSUE WITH ONE OF YOUR PRODUCTS. I WAS COKING AND TRYING TO SPIT IT OUT. IT WENT DOWN MY THROAT. I USED A LOT OF THE DIFFERENT KINDS OF YOUR PRODUCT AND I NEVER HAD A ISSUE. THIS IS NOT LIKE ANY GLUE I EVER HAD. IT IS HORRIBLE. IT DO NOT MAKE YOUR TEETH STICK. IT HAS BEEN HAPPENING FOR 3 DAYS. I BEEN USING IT FOR 3 DAYS. IT WILL NOT HOLD SO I HAVE TO KEEP PUTTING IT IN. BY THE TIME I AM AT WORK, IT IS COMING LOOSE. THAN I HAVE ALL THESE GLUE, I AM CHOKING ON. I AM YOUNG SO I AM ABLE TO DEAL WITH IT. BUT FOR ELDERLY PERSON THEY WILL CHOKE AND DIE. THIS IS DEFINITELY UNSAFE FOR AN ELDERLY PERSON. I JUST WANTED TO LET YOU KNOW. I DO NOT WANT ANYONE TO GET HURT. I DO NOT WANT YOU TO HAVE A LAWSUIT FROM AN OLD PERSON CHOKING AND DYING. I AM (B)(6) YEARS OLD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779887 POLIGRIP CUSHION COMFORT DENTURE ADHESIVE KOT ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH 252449

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other NO THERAPY, UNKNOWN