BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA DENTURE ADHESIVE CREAM

    MDR report key: 6538021 · Received May 2, 2017

    Report

    Report Number
    3003721894-2017-00206
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    January 15, 2010
    Report Date
    February 26, 2010
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT # 3003721894-2017-00206 IS ASSOCIATED WITH (B)(4), COREGA DENTURE ADHESIVE CREAM. COREGA DENTURE ADHESIVE CREAM IS MARKETED AS SUPER POLIGRIP IN THE U.S.

    Description of Event or Problem · 1

    TREMOR [TREMOR]; ABDOMINAL PAIN [ABDOMINAL PAIN]; ABNORMAL LAB RESULT [LAB TEST ABNORMAL]; HEPATIC CYST [HEPATIC CYST]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TREMOR IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA DENTURE ADHESIVE CREAM, NO FLAVOUR) CREAM FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PATIENT'S MEDICAL HISTORY INCLUDED TWO HERNIA OPERATION, HYPERTENSION AND PROSTATE PROBLEM. CONCURRENT MEDICATIONS INCLUDED NIFEDIPINE (ADALAT) AND DUTASTERIDE. ON AN UNKNOWN DATE IN (B)(6) 2010 THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (UNKNOWN) AS DIRECTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED TREMOR AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALISED 4 TIMES WITH THE SAME SYMPTOMS HAD SEVERAL LAB TESTS. THE PATIENT HAD ABNORMAL LAB TEST RESULTS RELATED TO LIVER PROBLEM ASSOCIATED WITH MEDIINES AND SMALL CYST ON LIVER WAS DIAGNOSED. THE PATIENT STOPPED TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) AFTER READING A MEDIA ARTICLE ABOUT COREGA RELATED HEALTH PROBLEMS. AT THE TIME OF REPORTING, TREMOR AND ABDOMINAL PAIN WERE RESOLVED AND THE OUTCOME OF THE OTHER EVENTS WAS UNKNOWN. CASE IDENTIFIED AS DUPLICATE ON 21 APRIL 2017: THIS CASE (B)(4) IS A DUPLICATE OF CASE (B)(4). THIS CASE (B)(4) WILL BE THE CASE OF RECORD AND ALL FUTURE CORRESPONDENCE SENT. CASE (B)(4) WILL BE DELETED AFTER ONE FINAL SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319672 COREGA DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization ADALAT (NIFEDIPINE)| DUTASTERIDE (DUTASTERIDE)