BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC

    MDR report key: 2861423 · Received November 29, 2012

    Report

    Report Number
    9681138-2012-00083
    Event Type
    Other
    Date Received
    November 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00083. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF AN ALLERGIC REACTION IN A (B)(6) MALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC FREE FORMULA)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT CONDITIONS INCLUDED OPEN WOUNDS FROM TEETH EXTRACTIONS PERFORMED ON (B)(6) 2012. ON (B)(6) 2012, THE PT STARTED DOUBLE SLT DENTAL ADHESIVE CREAM. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, THE PT EXPERIENCED IRREGULAR HEARTBEAT, DIM VISION, HEARING DECREASED AND CARDIAC DISCOMFORT DESCRIBED AS "I FELT LIKE I HAD LIGHTENING STRIKES GOING THROUGH MY HEART." THE PT ATTRIBUTED THESE EVENTS TO AN ALLERGIC REACTION TO DOUBLE SALT DENTAL ADHESIVE CREAM. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED ON (B)(6) 2012. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP EXTRA CARE WITH POLISEAL (ZINC DOUBLE SALT DENTAL ADHESIVE CREAM KOO GLAXOSMITHKLINE NA R12162

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other