BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 3772254 · Received March 27, 2014

    Report

    Report Number
    9681138-2014-00007
    Event Type
    Other
    Date Received
    March 27, 2014
    Report Date
    March 26, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REPORT FOR THIS CASE IS 9681138-2014-00007. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE (LOT V13241). IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF VOMITING IN A (B)(6) MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, THE PATIENT EXPERIENCED VOMITING. TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. CONSUMER REPORTED HE HAD BEEN THROWING UP EVERY DAY SINCE HE STARTED USING SUPER POLIGRIP SOMETIME IN (B)(6) 2014. CONSUMER STATED HE HAS USED 7 TUBES. AE FU RECEIVED (B)(4) 2014: CONSUMER REPORTED ADVERSE EVENT OF HE LOST 30 POUNDS FROM USING SUPER POLIGRIP. IT IS UNK IF THE EVENT IS STILL TAKING PLACE. WHEN CONSUMER WAS CONTACTED BACK, HE REPORTED AFTER HE HAD HIS BOTTOM TEETH EXTRACTED, HE STARTED USING SUPER POLIGRIP, HE REPORTED EVENT OF SICK FURTHER DESCRIBED AS SICK AS A DOG FROM USING SUPER POLIGRIP. HE WAS THROWING UP. HE ALSO THREW UP BLOOD ALL DAY AND ALL NIGHT. OVER FOUR WEEKS HE LOST BETWEEN 35 AND 36 POUNDS AND HE IS STILL LOSING WEIGHT. THERE WERE DAYS WHEN HE COULD NOT GO TO WORK. HE HAD TESTS, X-RAYS AND BLOOD WORK. HE SAID HIS DOCTOR DETERMINED THE SUPER POLIGRIP CAUSED HIS EVENTS. CONSUMER REPORTED HE HAD HIS DENTURES REALIGNED IN (B)(6) AND AGAIN ON (B)(6) 2014. CONSUMER REPORTED COUPLE OF DAYS FOR THE SUPER POLIGRIP TO GET OUT OF HIS SYSTEM. EVENTS OF THROWING UP, THROWING UP BLOOD AND SICK HAVE RESOLVED. EVENT OF LOSING EIGHT CONTINUES. CONSUMER WAS EXPLAINED THE COMPENSATION PROCEDURE AND REFUSED TO RETURN THE PRODUCT. HE SAID IT WAS TOO MUCH WORK FOR HIM TO GO THROUGH AND SAID HE WOULD CONTACT HIS LAWYER INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183231 SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA V13241

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other