BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 559370 · Received December 9, 2004

    Report

    Report Number
    2650037-2004-00010
    Event Type
    Other
    Date Received
    December 9, 2004
    Date of Event
    January 1, 1994
    Report Date
    December 8, 2004
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESRIBED THE OCCURRENCE OF NEW ONSET DIABETES MELLITUS IN A PT WHO RECEIVED POLIGRIP (SUPER POLIGRIP-UNIDENTIFIED) CREAM FOR LOOSE DENTURES. THE CONSUMER CALLED TO PRAISE PRODUCT, REQUEST COUPONS AND MAKE A GENERAL PRODUCT COMMENT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ACID REFLUX, ALLERGIC TO GLUCOPHAGE, IODINE ALLERGY AND IODINE DYE ALLERGY. CONCURRENT MEDICATIONS INCLUDED ZYRTEC AND NEXIUM. THE PT HAS BEEN USING POLIGRIP (DENTAL) FOR "TWENTY TO THIRTY YEARS". IN 1994, THE PT WAS DIAGNOSED WITH NEW ONSET DIABETES MELLITUS AND TREATED WITH INSULIN LISPRO (HUMALOG INSULIN). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIGRIP WAS CONTINUED. THE OUTCOME OF THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP DENTURE ADHESIVE KOP GLAXOSMITHKLINE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other CETIRIZINE HYDROCHLORIDE, UNK, ESOMEPRAZEL, UNK.