BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPER POLIGRIP DENTURE ADHESIVE POWDER

    MDR report key: 6716651 · Received July 17, 2017

    Report

    Report Number
    3003721894-2017-00342
    Event Type
    Death
    Date Received
    July 17, 2017
    Report Date
    July 11, 2017
    Manufacturer
    GLAXOSMITHKLINE DUNGARVAN LTD
    Product Code
    KOT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MFR 3003721894-2017-00342 IS ASSOCIATED WITH ARGUS CASE (B)(4), SUPER POLIGRIP DENTURE ADHESIVE POWDER.

    Description of Event or Problem · 1

    MY GRANDFATHER DIED AND I WANT TO KNOW IF I CAN DONATE THESE [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A MALE PATIENT WHO RECEIVED DENTURE ADHESIVE POWDER-DOUBLE SALT (SUPER POLIGRIP DENTURE ADHESIVE POWDER) ORAL POWDER (BATCH NUMBER AJ5A, EXPIRY DATE UNKNOWN) FOR ORAL HYGIENE. CO-SUSPECT PRODUCTS INCLUDED DENTURE ADHESIVE POWDER-DOUBLE SALT (SUPER POLIGRIP DENTURE ADHESIVE POWDER) ORAL POWDER (BATCH NUMBER N13414, EXPIRY DATE UNKNOWN) FOR DENTAL DISORDER PROPHYLAXIS. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP DENTURE ADHESIVE POWDER AND SUPER POLIGRIP DENTURE ADHESIVE POWDER. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP DENTURE ADHESIVE POWDER AND SUPER POLIGRIP DENTURE ADHESIVE POWDER, THE PATIENT EXPERIENCED UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). SUPER POLIGRIP DENTURE ADHESIVE POWDER WAS DISCONTINUED. ON AN UNKNOWN DATE, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE RELATED TO SUPER POLIGRIP DENTURE ADHESIVE POWDER AND SUPER POLIGRIP DENTURE ADHESIVE POWDER. ADDITIONAL DETAILS: THIS ADVERSE EVENT INFORMATION WAS RECEIVED ON 11 JULY 2017. THE PRODUCT WAS SUPER POLIGRIP POWDER. THE CONSUMER STATED, "MY GRANDFATHER DIED AND I WANT TO KNOW IF I CAN DONATE THESE. THE LOT WAS AJ5A. I HAVE ANOTHER ONE WITH A LOT OF N13414. THE CONSUMER DID NOT SPECIFY WHETHER OR NOT THE LOTS PROVIDED WERE FOR OPENED BOXES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498115 SUPER POLIGRIP DENTURE ADHESIVE POWDER DENTURE ADHESIVE KOT GLAXOSMITHKLINE DUNGARVAN LTD AJ5A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O NO THERAPY (NO THERAPY)