BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 3688144 · Received March 3, 2014

    Report

    Report Number
    9681138-2014-00004
    Event Type
    Other
    Date Received
    March 3, 2014
    Report Date
    February 28, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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'S NIECE (VIA (B)(4)) AND DESCRIBED THE OCCURRENCE OF STROKE IN A FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (SUPER POLIGRIP) FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK) (DENTAL) AS DIRECTED. AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PATIENT EXPERIENCED STROKE. THE PATIENT'S NIECE REPORTED THAT HER AUNT (THE PATIENT) BELIEVES THAT SUPER POLIGRIP WITH ZINC CAUSED HER TO HAVE A STROKE. THE PATIENT'S NIECE REPORTED THAT SHE DID NOT BELIEVE THIS TO BE TRUE BECAUSE HER AUNT WAS FUNCTIONING IRRATIONALLY AFTER HER STROKE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128747 POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other