BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 8074940 · Received November 15, 2018

    Report

    Report Number
    3003721894-2018-00403
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 7, 2018
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), SUPER POLIGRIP FREE. PRODUCT QUALITY INVESTIGATION (05691035/7377428) 15 NOVEMBER 2018: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT SO A FULL INVESTIGATION COULD NOT BE COMPLETED. THE BATCH NUMBER PROVIDED IS ALSO INVALID. ON THIS BASIS WE ARE UNABLE TO INVESTIGATE THIS COMPLAINT FURTHER. ALL OF THE DOCUMENTATION PERTINENT TO A SPECIFIC LOT OF FINISHED PRODUCT IS CONTAINED IN A 'BATCH ENVELOPE'. PRIOR TO THE DISPOSITION OF THE PRODUCT, THE CONTENTS OF EACH BATCH ENVELOPE IS REVIEWED & APPROVED BY THE SITE QUALITY DEPARTMENT TO VERIFY THAT THERE WERE NO SIGNIFICANT QUALITY ISSUES RECORDED DURING MANUFACTURING, PACKAGING OR TESTING. THIS REVIEW ALSO VERIFIES THAT ALL TEST RESULTS MEET SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM) CREAM (BATCH NUMBER UY26, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON (B)(6) 2018, THE PATIENT STARTED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), APHASIA, DIFFICULTY BREATHING AND PRODUCT PHYSICAL CONSISTENCY ISSUE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM WAS DISCONTINUED ON (B)(6) 2018 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL DEVICE INGESTION, APHASIA, DIFFICULTY BREATHING, PRODUCT PHYSICAL CONSISTENCY ISSUE AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING, APHASIA AND DIFFICULTY BREATHING TO BE RELATED TO SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. 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 VIA CALL ON 07 NOVEMBER 2018. THE CONSUMER REPORTED THAT, "I PURCHASED A TUBE OF SUPER POLIGRIP AND IT SAYS NEW LOOK ON IT AND IT'S THE 0.75 OZ I WANTED TO TRY IT FOR MY DENTURES BECAUSE MY DENTIST HASN'T DONE THE RIGHT THING OF MAKING THEM FIT. ANYWAY, I PUT SOME OF THE SUPER POLIGRIP AND I WENT BY THE DIAGRAM ON THE BACK OF HOW TO APPLY THE SUPER GRIP IN SHORT LITTLE STRIPS. I DID THAT YESTERDAY MORNING AND WE LEFT OUR HOUSE AT 11AM AND WE HAD TO GO TO A VERY IMPORTANT CONFERENCE OUT OF TOWN. I PUT THIS SUPER POLIGRIP IN, I WENT TO TAKE MY DENTURES OUT LAST NIGHT AT APPROXIMATELY 8PM AND I HAD A HARD TIME GETTING THEM OUT IT WAS NOT EVEN FUNNY. AFTER I TOOK THEM OUT, I HAD A MOUTHFUL OF SUPER POLIGRIP. THE STUFF HAD MELTED AND I MEAN MELTED AND THEN THE SUPER POLIGRIP PROCEEDED TO GO DOWN MY THROAT AND IT ALMOST CUT MY WIND PIPE OFF AND I WAS NOT ABLE TO BREATHE. I HAD TO KEEP LITERALLY WIPING THE ROOF OF MY MOUTH OFF ALL AROUND MY GUMS AND THE ROOF OF MY MOUTH. I ALMOST HAD MY HUSBAND TAKE ME TO THE HOSPITAL. I COULD NOT EVEN TALK. I HAD ALL OF THAT GLUE IN MY MOUTH. I JUST WANTED TO CALL YOU AND YOU CAN PASS IT ON TO WHOEVER. WOULD LIKE TO KNOW IN WRITING, WHAT THEY WOULD HAVE DONE IF I WOULD HAVE ENDED UP IN THE HOSPITAL LAST NIGHT. THIS IS HORRIBLE. I ALMOST CHOKED TO DEATH." FOLLOW UP INFORMATION WAS RECEIVED ON 15 NOVEMBER 2018 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT NUMBER 7377428(ISSUE NUMBER), FOR LOT NUMBER UY26 (INVALID). THE INVESTIGATION REPORT INCLUDED THAT, THE PRODUCT SAMPLE WAS NOT RECEIVED. THE INVESTIGATION REPORT INCLUDED THAT, NO SAMPLE WAS RETURNED FOR THIS COMPLAINT SO A FULL INVESTIGATION COULD NOT BE COMPLETED. THE BATCH NUMBER PROVIDED IS ALSO INVALID. ON THIS BASIS WE ARE UNABLE TO INVESTIGATE THIS COMPLAINT FURTHER. QA ANALYSIS REVEALED THE COMPLAINT TO BE UNSUBSTANTIATED. LOT NUMBER UPDATED FROM UY26 (FOUND INVALID)TO UNKNOWN.

    Additional Manufacturer Narrative · 1

    MFR REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), SUPER POLIGRIP FREE.

    Description of Event or Problem · 1

    I ALMOST CHOKED TO DEATH [CHOKING]. THE SUPER POLIGRIP PROCEEDED TO GO DOWN MY THROAT AND IT ALMOST CUT MY WIND PIPE OFF AND I WASN'T ABLE TO BREATHE [ACCIDENTAL DEVICE INGESTION] [DIFFICULTY BREATHING]. I COULDN'T EVEN TALK [APHASIA]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM) CREAM (BATCH NUMBER UY26, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON (B)(6) 2018, THE PATIENT STARTED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), APHASIA, DIFFICULTY BREATHING AND PRODUCT PHYSICAL CONSISTENCY ISSUE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM WAS DISCONTINUED ON (B)(6) 2018 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL DEVICE INGESTION, APHASIA, DIFFICULTY BREATHING, PRODUCT PHYSICAL CONSISTENCY ISSUE AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING, APHASIA AND DIFFICULTY BREATHING TO BE RELATED TO SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON (B)(6) 2018. THE CONSUMER REPORTED THAT, "I PURCHASED A TUBE OF SUPER POLIGRIP AND IT SAYS NEW LOOK ON IT AND IT'S THE 0.75 OZ I WANTED TO TRY IT FOR MY DENTURES BECAUSE MY DENTIST HASN'T DONE THE RIGHT THING OF MAKING THEM FIT. ANYWAY, I PUT SOME OF THE SUPER POLIGRIP AND I WENT BY THE DIAGRAM ON THE BACK OF HOW TO APPLY THE SUPER GRIP IN SHORT LITTLE STRIPS. I DID THAT YESTERDAY MORNING AND WE LEFT OUR HOUSE AT 11AM AND WE HAD TO GO TO A VERY IMPORTANT CONFERENCE OUT OF TOWN. I PUT THIS SUPER POLIGRIP IN, I WENT TO TAKE MY DENTURES OUT LAST NIGHT AT APPROXIMATELY 8PM AND I HAD A HARD TIME GETTING THEM OUT IT WAS NOT EVEN FUNNY. AFTER I TOOK THEM OUT, I HAD A MOUTHFUL OF SUPER POLIGRIP. THE STUFF HAD MELTED AND I MEAN MELTED AND THEN THE SUPER POLIGRIP PROCEEDED TO GO DOWN MY THROAT AND IT ALMOST CUT MY WIND PIPE OFF AND I WAS NOT ABLE TO BREATHE. I HAD TO KEEP LITERALLY WIPING THE ROOF OF MY MOUTH OFF ALL AROUND MY GUMS AND THE ROOF OF MY MOUTH. I ALMOST HAD MY HUSBAND TAKE ME TO THE HOSPITAL. I COULD NOT EVEN TALK. I HAD ALL OF THAT GLUE IN MY MOUTH. I JUST WANTED TO CALL YOU AND YOU CAN PASS IT ON TO WHOEVER. WOULD LIKE TO KNOW IN WRITING, WHAT THEY WOULD HAVE DONE IF I WOULD HAVE ENDED UP IN THE HOSPITAL LAST NIGHT. THIS IS HORRIBLE. I ALMOST CHOKED TO DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912847 SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD UY26

    Patients

    Seq Age Sex Outcome Treatment
    1 Other