BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER POLIGRIP

    MDR report key: 2245303 · Received September 8, 2011

    Report

    Report Number
    9681138-2011-00234
    Event Type
    Death
    Date Received
    September 8, 2011
    Report Date
    September 7, 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 MFG IN (B)(4), AND NEITHER THE PRODUCT NOT 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 LOSS OF STRENGTH IN A (B)(6) FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (SUPER POLIGRIP) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK). AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PT EXPERIENCED LOSS OF STRENGTH, FEELING UNWELL, ADVERSE EVENT AND DEATH OF UNK CAUSE. AT THE TIME OF REPORTING, THE EVENTS WERE FATAL. THE PT DIED ON (B)(6) 2011 FROM UNK CAUSE OF DEATH. AN AUTOPSY WAS NOT PERFORMED. THIS CASE WAS REPORTED BY AN ACQUAINTANCE OF A CONSUMER AND DESCRIBED THE EXPERIENCES OF NO STRENGTH AND NEVER FELT GOOD WHEN USING SUPER POLIGRIP. CONSUMER REPORTED THAT HER FRIEND HAD TO HAVE HER BLOOD CHECKED MONTHLY AND SHE DID NOT KNOW THE REASON AS TO WHY THE BLOOD NEEDED TO BE CHECKED. CONSUMER THEN REPORTED THAT HER FRIEND PASSED AWAY ON (B)(6) 2011 AND THE CAUSE OF DEATH IS UNK. I ASKED CONSUMER IF SUPER POLIGRIP HAD ANYTHING TO DO WITH HER FRIEND'S DEATH AND SHE SAID THAT SHE DOESN'T KNOW NOR DOES SHE KNOW THE CAUSE OF DEATH. CONSUMER REPORTED THAT HER FRIEND HAD TO HAVE BLOOD WORK TAKEN MONTHLY BECAUSE SHE NEVER FELT WELL. CONSUMER WAS UNABLE TO PROVIDE ANY FURTHER DETAIL AS TO THE DATES WHEN THIS HAPPENED.

    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 69 YR Death