BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA DENTURE ADHESIVE CREAM

    MDR report key: 4121403 · Received September 23, 2014

    Report

    Report Number
    9681138-2014-00023
    Event Type
    Other
    Date Received
    September 23, 2014
    Report Date
    September 22, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GSK DENTURE ADHESIVE (COREGA DENTURE ADHESIVE CREAM) IS MANUFACTURED IN (B)(4). THE PRODUCT AND LOT NUMBER FOR THIS PRODUCT ARE NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER'S NEIGHBOR (WHO IS A DISTRIBUTOR) AND DESCRIBED THE OCCURRENCE OF HEMIPLEGIA IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (COREGA DENTURE ADHESIVE CREAM) FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK) (DENTAL). AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PATIENT EXPERIENCED HEMIPLEGIA AND FACIAL PARALYSIS. THE PATIENT'S NEIGHBOR REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HEMIPLEGIA AND FACIAL PARALYSIS (UNK CAUSE). THE PATIENT WAS HOSPITALIZED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE REPORTER CONSIDERED THE EVENT TO BE NOT RELATED TO TREATMENT WITH COREGA DENTURE ADHESIVE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591297 COREGA DENTURE ADHESIVE CREAM GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization