BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (FREE AND ORIGINAL)

    MDR report key: 1912767 · Received November 2, 2010

    Report

    Report Number
    9681138-2010-00372
    Event Type
    Other
    Date Received
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: R08485. THE LOT NUMBERS FOR THESE PRODUCTS IS KNOWN; HOWEVER, IT IS UNK WHETHER THE PRODUCTS 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 MEMORY LOSS IN A (B)(6) MALE PT WHO REC'D SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM ((B)(4)) AND SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE(S), THE PT STARTED THE FORMULATIONS OF SUPER POLIGRIP. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED MEMORY LOSS, JOINT LOCK, "BODY LOCKS" (ADVERSE EVENT), INABILITY TO SLEEP, HEADACHE, INABILITY TO LIE DOWN (ILL-DEFINED DISORDER), PAIN, INABILITY TO MOVE, BLACKOUT, BEING UNABLE TO SEE, AND SPOTS IN EYE. THE PT SAID "I AM GETTING WORSE" (CONDITION AGGRAVATED). THE PT SAID "MY DOCTOR TOLD ME I AM PROBABLY GOING BLIND." THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP FORMULATIONS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE GETTING WORSE. THE FORMULATIONS OF SUPER POLIGRIP ARE MANUFACTURED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FREE AND ORIGINAL) DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE R08334A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other