BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (VARIANT UNK)

    MDR report key: 1812570 · Received August 16, 2010

    Report

    Report Number
    9681138-2010-00293
    Event Type
    Other
    Date Received
    August 16, 2010
    Report Date
    August 16, 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

    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 BRAIN ANEURYSM IN A FEMALE PT WHO RECEIVED SUPER POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PT STARTED SUPER POLIGRIP (DENTAL). IN 1999, THE PT EXPERIENCED BRAIN ANEURYSM. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. CONSUMER REPORTED THAT SHE HAD A BRAIN ANEURYSM IN 1999. NO OTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other