BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GSK DENTURE ADHESIVE (FORM UNKOWN)

    MDR report key: 4543881 · Received February 24, 2015

    Report

    Report Number
    9681138-2015-00007
    Event Type
    Injury
    Date Received
    February 24, 2015
    Report Date
    February 1, 2015
    Manufacturer
    GSK DUNGARVAN STAFFORD MILLER
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ULCER DISEASE EXACERBATION [ULCER]. BLEEDING [HEMORRHAGE]. NAUSEA . VOMITING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA PT SUPPORT PROGRAMS AND DESCRIBED THE OCCURRENCE OF ULCER IN A (B)(6) FEMALE PT WHO REC'D GSK DENTURE ADHESIVE (FORMULATION UNK) (GSK DENTURE ADHESIVE (FORM UNK)) CREAM FOR DENTURE WEARER. ON AN UNK DATE, THE PT STARTED GSK DENTURE ADHESIVE (FORM UNK). ON AN UNK DATE, AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORM UNK), THE PT EXPERIENCED ULCER (SERIOUS CRITERIA HOSPITALIZATION), HEMORRHAGE (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), NAUSEA AND VOMITING. ON AN UNK DATE, THE OUTCOME OF THE ULCER, HEMORRHAGE, NAUSEA AND VOMITING WERE NOT REPORTED. THE REPORTER CONSIDERED THE ULCER, HEMORRHAGE, NAUSEA AND VOMITING TO BE RELATED TO GSK DENTURE ADHESIVE (FORM UNK). ADD'L DETAILS: CASE REC'D FROM CONSUMER VIA COREGA HOT LINE. A WOMAN OF (B)(6) DEVELOPED NAUSEA, VOMITING, ULCER DISEASE EXACERBATION AND BLEEDING (LOCALIZATION WAS NOT SPECIFIED) RIGHT AFTER SHE STARTED COREGA EXTRA STRONG MINT TASTE. SHE WAS HOSPITALIZED TO INTENSIVE CARE UNIT. NO OTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129079 GSK DENTURE ADHESIVE (FORM UNKOWN) DENTURE ADHESIVE KOL GSK DUNGARVAN STAFFORD MILLER

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O