BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE ADHESIVE CREAM

    MDR report key: 16434671 · Received February 24, 2023

    Report

    Report Number
    3003721894-2023-00022
    Event Type
    Injury
    Date Received
    February 24, 2023
    Report Date
    February 3, 2023
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 0

    SO HE THINKS HE SWALLOWED IT. [ACCIDENTAL DEVICE INGESTION]. A HEART VESSEL WAS BLOCKED. HE ASSUMES THAT IT IS BECAUSE OF THE PRODUCT [HEART BLOCK]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIDENT DENTURE ADHESIVE CREAM) CREAM (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DENTURE WEARER. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCURRENT MEDICAL CONDITIONS INCLUDED HYPERTENSION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTURE ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: HALEON MEDICALLY SIGNIFICANT), HEART BLOCK AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIDENT DENTURE ADHESIVE CREAM WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, HEART BLOCK AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT DENTURE ADHESIVE CREAM. THE REPORTER CONSIDERED THE HEART BLOCK TO BE POSSIBLY RELATED TO POLIDENT DENTURE ADHESIVE CREAM. THIS REPORT IS MADE BY GSK/HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED BY CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 03FEB2023. CONSUMER REPORTED THAT "HAVE BEEN USING POLIDENT ADHESIVE CREAM FOR ABOUT 1 YEAR. WHEN USING, HE WILL GO TO SLEEP WITHOUT REMOVING THE DENTURES. WHEN HE WAKES UP, THE ADHESIVE CREAM IS ALL MELTED AND GONE. SO HE THINKS HE SWALLOWED IT. HE DID A HEALTH CHECK RECENTLY AND HE GOT A RESULT THAT A HEART VESSEL WAS BLOCKED. HE ASSUMES THAT IT IS BECAUSE OF THE PRODUCT. ILLNESS / OTHER MEDICATION : HYPERTENSION/HYPERTENSION MEDICATION". FOLLOW UP INFORMATION WAS RECEIVED ON 07FEB2023 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT (B)(4) (PQC 181522) FOR UNKNOWN LOT NUMBER. INVESTIGATION EVALUATION: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT, ALSO BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED. 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. DUE TO THE ADVERSE EVENT AND RELATED HSI, COULD I KINDLY REQUEST THAT FURTHER INFORMATION IS REQUESTED FROM THE COMPLAINANT. ONCE ADDITIONAL INFORMATION IS AVAILABLE THE CASE WILL BE REOPENED AND FURTHER INVESTIGATION WILL BE PERFORMED. THE INVESTIGATION REPORTS CONCLUDED THAT, COMPLAINT STANDS UNSUBSTANTIATED. INITIAL AND FOLLOW UP DOCUMENTS WERE PROCESSED TOGETHER. FOLLOW UP INFORMATION WAS RECEIVED ON 14FEB2023. AS PER FOLLOW UP INFORMATION, PATIENT MEDICAL HISTORY WAS UPDATED AS PATIENT TRIED TO DO A BLOOD VESSEL PROCEDURE. TREATMENT DRUG WAS UPDATED AS ASPIRIN WITH HEART BLOCK AS INDICATION. IT WAS REPORTED THAT, "I TRIED TO DO A BLOOD VESSEL PROCEDURE, BUT THE BLOOD VESSEL WAS TOO SMALL TO FIT THE STENT. I'M TAKING ASPIRIN BECAUSE I HEARD IT'S ONLY POSSIBLE WITH MEDICATION TREATMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871052 POLIDENT DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other 1) NO THERAPY (NO THERAPY).