BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA DENTURE ADHESIVE FORMULATION UNKNOWN

    MDR report key: 11193792 · Received January 19, 2021

    Report

    Report Number
    3003721894-2021-00020
    Event Type
    Injury
    Date Received
    January 19, 2021
    Report Date
    January 10, 2021
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 FACEBOOK INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF DIABETES IN A MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA DENTURE ADHESIVE FORMULATION UNKNOWN) UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA DENTURE ADHESIVE FORMULATION UNKNOWN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA DENTURE ADHESIVE FORMULATION UNKNOWN, THE PATIENT EXPERIENCED DIABETES (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SALIVATION AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH COREGA DENTURE ADHESIVE FORMULATION UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DIABETES, SALIVATION AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DIABETES AND SALIVATION TO BE RELATED TO COREGA DENTURE ADHESIVE FORMULATION UNKNOWN. ADDITIONAL DETAIL: PATIENT STATED THAT MINE DID NOT HOLD, BECAUSE OF THE DIABETES OR TOO MUCH SALIVATION. PRODUCT QUALITY COMPLAINTS (B)(4) RELATED CASE (B)(4). PATIENT NOT TREATED BY AN HCP (HEALTH CARE PROFESSIONAL). REPORTER DID NOT CONSENTED TO FOLLOW UP. REPORTER DID NOT AUTHORIZED FOLLOW UP WITH HCP. NAME OF PRODUCT QUALITY COMPLAINT: (B)(4), LEVEL 2, REASON CODE: PERFORMANCE COMPLAINT LEVEL 3 REASON CODE: PRODUCT DID NOT HOLD. RELATED TO AN HSI (HUMAN SAFETY INFORMATION) WITH AN AE (ADVERSE EVENT): REPORTED SIDE EFFECTS VERBATIM: WHY PATIENT NOT INSURE COMPLAINT. CONCLUSION: PQC (PRODUCT QUALITY COMPLAINTS) EVALUATION: RESPONSE TO CONSUMER: CASE NUMBER OF RELATED. CASE IN PQC TYPE: (B)(4). DATE OF RELATED CASE IN PQC TYPE: (B)(6) 2021. FOLLOW UP INFORMATION RECEIVED ON 14 JAN 2021 FROM QUALITY ASSURANCE DEPARTMENT REGARDING COMPLAINT NUMBER ((B)(4)) (COMPLAINT REFERENCE) FOR UNKNOWN LOT NUMBER: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT AND THE LOT/BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION CANNOT BE COMPLETED. AS THIS INFORMATION WAS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED AND WOULD BE CLOSED AS INCONCLUSIVE. IF THE CONSUMER CONTACTS WITH ADDITIONAL INFORMATION OR IF THE COMPLAINT SAMPLE WAS RECEIVED, THE COMPLAINT ISSUE WOULD BE REOPENED AND FURTHER EVALUATED. QUALITY ASSURANCE ANALYSIS REVEALED THE COMPLAINT TO BE INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    DIABETES [DIABETES], TOO MUCH SALIVATION [SALIVATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA FACEBOOK INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF DIABETES IN A MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA DENTURE ADHESIVE FORMULATION UNKNOWN) UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA DENTURE ADHESIVE FORMULATION UNKNOWN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA DENTURE ADHESIVE FORMULATION UNKNOWN, THE PATIENT EXPERIENCED DIABETES (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SALIVATION AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH COREGA DENTURE ADHESIVE FORMULATION UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DIABETES, SALIVATION AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DIABETES AND SALIVATION TO BE RELATED TO COREGA DENTURE ADHESIVE FORMULATION UNKNOWN. ADDITIONAL DETAIL: PATIENT STATED THAT MINE DID NOT HOLD, BECAUSE OF THE DIABETES OR TOO MUCH SALIVATION. PRODUCT QUALITY COMPLAINTS (B)(4) RELATED CASE 01562809. PATIENT NOT TREATED BY AN HCP (HEALTH CARE PROFESSIONAL). REPORTER DID NOT CONSENTED TO FOLLOW UP. REPORTER DID NOT AUTHORIZED FOLLOW UP WITH HCP. NAME OF PRODUCT QUALITY COMPLAINT: (B)(4), LEVEL 2, REASON CODE: PERFORMANCE COMPLAINT LEVEL 3 REASON CODE: PRODUCT DID NOT HOLD. RELATED TO AN HSI (HUMAN SAFETY INFORMATION) WITH AN AE (ADVERSE EVENT): REPORTED SIDE EFFECTS VERBATIM: WHY PATIENT NOT INSURE COMPLAINT. CONCLUSION: PQC (PRODUCT QUALITY COMPLAINTS) EVALUATION: RESPONSE TO CONSUMER: CASE NUMBER OF RELATED. CASE IN PQC TYPE: (B)(4). DATE OF RELATED CASE IN PQC TYPE: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91734 COREGA DENTURE ADHESIVE FORMULATION UNKNOWN DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other