BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2020231 · Received March 9, 2011

    Report

    Report Number
    9681138-2011-00063
    Event Type
    Other
    Date Received
    March 9, 2011
    Report Date
    March 8, 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 ASTHMATIC ATTACK IN A FEMALE PATIENT WHO RECEIVED AN UNSPECIFIED CREAM FORMULATION OF SUPER POLIGRIP FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED AN ASTHMATIC ATTACK, COUGH, SICKNESS AND PRODUCT COMPLAINT OF OOZING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. CONSUMER REPORTED THAT SHE USED A DENTURE ADHESIVE CREAM IN THE PAST BUT COULD NOT RECALL WHICH PRODUCT IT WAS. SHE STATED THAT IT CAUSED HER TO HAVE ASTHMA ATTACKS, COUGHING AND MADE HER SICK. THE EVENTS OF ASTHMA ATTACK, COUGHING AND MADE HER SICK ARE RESOLVED. CONSUMER REPORTED A PRODUCT COMPLAINT OF OOZING. NO CONTACT INFORMATION WAS PROVIDED; THEREFORE, THIS CASE IS LOST TO FOLLOW-UP.

    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