BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP EX CREAM

    MDR report key: 1403366 · Received June 15, 2009

    Report

    Report Number
    9681138-2009-00110
    Event Type
    Other
    Date Received
    June 15, 2009
    Report Date
    June 15, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A DRUG STORE MANAGER, AND DESCRIBED THE OCCURRENCE OF DYSPEPSIA IN A MALE PT, WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (POLIGRIP EX) FOR LOOSE DENTURE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP FREE) WITH WHICH THE PT EXPERIENCED NO ADVERSE REACTIONS. ON AN UNKNOWN DATE, THE PT POLIGRIP EX., AT AN UNKNOWN TIME AFTER STARTING THE PRODUCT, THE PT EXPERIENCED DYSPEPSIA AND NAUSEA. IT WAS REPORTED THAT THE PT VISITED THE HOSPITAL DUE TO THESE SYMPTOMS (DETAILS OF VISIT/ADMISSION WERE UNK). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. POLIGRIP EX IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP EX CREAM DENTURE ADHESIVE KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization