BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2011692 · Received March 1, 2011

    Report

    Report Number
    9681138-2011-00054
    Event Type
    Other
    Date Received
    March 1, 2011
    Report Date
    February 28, 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 IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SICKNESS IN A FEMALE PT WHO RECEIVED SUPER POLIGRIP (FORMULATION UNK) (SUPER POLIGRIP) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED SICKNESS AND BLOOD DISORDER. THE PT SAID "I'M HAVING TROUBLE WITH MY BLOOD". THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PT INDICATED THAT SHE WILL UNDERGO A BONE MARROW BIOPSY AND ADD'L BLOODWORK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. THE PT COULD NOT PROVIDE LOT CODE AND IS NOT RETURNING PRODUCT. SHE INDICATED THAT SHE MAY BE CONTACTING AN ATTORNEY. THE PT CALLED GSK AFTER HER MOTHER SAW A LEGAL ADVERTISEMENT ON TELEVISION. ATTEMPT TO REACH CALLER FOR ADD'L INFO WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other