BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 2163608 · Received June 8, 2011

    Report

    Report Number
    9681138-2011-00141
    Event Type
    Other
    Date Received
    June 8, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP FREE IS MFG IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE (X10233A). IT IS UNK IF 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 ALMOST CHOKED IN A (B)(6) FEMALE PT WHO RECEIVE SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP FREE (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP FREE, THE PT EXPERIENCED ALMOST CHOKED, RAW GUMS, DISTRESS AND PRODUCT COMPLAINT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP FREE WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. CONSUMER REPORTED THAT WHEN THE PRODUCT OOZED OUT, IT ALMOST CHOKED HER. SHE REPORTED THAT SHE WAS IN DISTRESS FOR AWHILE. THE CONSUMER ALSO REPORTED THE PRODUCT COMPLAINT OF TEXTURE OFF, OOZING AND ADHESIVE HARD TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA X10233A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other