BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIGRIP CUSHION COMFORT

    MDR report key: 10065996 · Received May 18, 2020

    Report

    Report Number
    3003341442-2020-00008
    Event Type
    Injury
    Date Received
    May 18, 2020
    Report Date
    April 20, 2020
    Manufacturer
    ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4). CONCOMITANT MEDICAL PRODUCTS (CONTINUED): 2) NO THERAPY (NO THERAPY) UNKNOWN.

    Description of Event or Problem · 1

    IT LITERALLY ALMOST MADE ME CHOKE [CHOKING]. 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 241439, EXPIRY DATE 17TH OCTOBER 2022) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM) AND NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIGRIP CUSHION COMFORT. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIGRIP CUSHION COMFORT AND SUPER POLIGRIP REGULAR DENTURE ADHESIVE CREAM, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIGRIP CUSHION COMFORT WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO POLIGRIP CUSHION COMFORT. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL CENTER REPRESENTATIVE (CALL) ON 20 APRIL 2020. CONSUMER REPORTED THAT, "SUPER POLIGRIP, I HAD DENTURES FOR APPROXIMATELY 15 YEARS, MOST OF THE TIME I USE THE REGULAR POLIGRIP WHICH I APPRECIATE A LOT. OKAY, SO, YOU HAVE THIS NEW PRODUCT CUSHION AND COMFORT, DO NOT LIKE IT. IT LITERALLY ALMOST MADE ME CHOKE ITS REAL GRIDY AND CHALKY AND IT IS REALLY HARD TO GET OUT OF MY MOUTH. I DO NOT HAVE THE RECEIPT. I HAVE THE BOX BUT I WOULD LIKE TO GET A REFUND OR AT LEAST COUPONS." FOLLOW UP INFORMATION WAS RECEIVED ON 24 APRIL 2020 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT (B)(4) (ISSUE NUMBER FOR PRODUCT ADHESIVE IS HARD TO REMOVE) AND (B)(4) (PRODUCT CONSISTENCY OR TEXTURE IS UNCHARACTERISTIC) FOR LOT NUMBER 241439. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS UNSUBSTANTIATED. COMPLAINT SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE. THE BATCH DOCUMENTATION OF COMPLAINT SAMPLES WAS CHECKED, AND NO DEVIATIONS FOUND WHICH COULD HAVE A NEGATIVE IMPACT TO THE ADHESIVE. NO FURTHER INVESTIGATION POSSIBLE. THE COMPLAINT WAS UNSUBSTANTIATED. FOLLOW UP INFORMATION WAS RECEIVED ON 12 MAY 2020 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT (B)(4) (ISSUE NUMBER FOR PRODUCT ADHESIVE IS HARD TO REMOVE) AND (B)(4) (PRODUCT CONSISTENCY OR TEXTURE IS UNCHARACTERISTIC) FOR LOT NUMBER 241439. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS UNSUBSTANTIATED. COMPLAINT SAMPLE WAS RECEIVED AT INVESTIGATION SITE. THE BATCH DOCUMENTATION OF COMPLAINT SAMPLES WAS CHECKED, AND NO DEVIATIONS FOUND WHICH COULD HAVE A NEGATIVE IMPACT TO THE ADHESIVE STRENGTH. NO FURTHER INVESTIGATION POSSIBLE. THE COMPLAINT WAS UNSUBSTANTIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530964 POLIGRIP CUSHION COMFORT DENTURE ADHESIVE KOT ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH 241439

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other