BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2919837 · Received January 14, 2013

    Report

    Report Number
    9681138-2013-00001
    Event Type
    Other
    Date Received
    January 14, 2013
    Report Date
    January 11, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00001. 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 INCREASED BLOOD PRESSURE IN A (B)(6) FEMALE PATIENT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED CALCIUM SODIUM POLY (VINYL METHYL ETHER-MALEATE) (FIXODENT), UNSPECIFIED DENTURE ADHESIVE WAFER AND SEA BOND DENTURE ADHESIVE. ON AN UNKNOWN DATE(S), THE PATIENT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM, CALCIUM SODIUM POLY (VINYL METHYL ETHER-MELEATE) UNSPECIFIED DENTURE ADHESIVE WAFER AND SEA BOND DENTURE ADHESIVE. AT AN UNKNOWN TIME AFTER SODIUM POLY (VINYL METHYL ETHER-MALEATE) UNSPECIFIED DENTURE ADHESIVE WAFER AND SEA BOND DENTURE ADHESIVE, THE PATIENT EXPERIENCED INCREASED BLOOD PRESSURE AND ALLERGIC REACTION. THE PATIENT WAS HOSPITALIZED. TREATMENT WITH TRIPLE SALT DENTAL ADHESIVE CREAM, FIXODENT, SEA BOND AND UNSPECIFIED DENTURE ADHESIVE WAFER WAS DISCONTINUED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTI-HYPERTENSIVE. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. CONSUMER REPORTED THAT SHE USED AN UNKNOWN VARIANT OF THE SUPER POLIGRIP CREAM WITH ZINC AT LEAST 5 YEARS AGO OR MORE WHEN SHE WAS APPROXIMATELY (B)(6) AND HER BLOOD PRESSURE SHOT WAY UP AND SHE ALMOST HAD A STROKE. CONSUMER REPORTED THAT SHE WAS ADMITTED TO THE HOSPITAL AND KEPT OVERNIGHT. SHE STATED THAT SHE WAS RELEASED WITH BLOOD PRESSURE MEDICATION. THE CONSUMER INDICATED THAT THE USE OF SUPER POLIGRIP WITH ZINC WAS DISCONTINUED AND THE EVENT OF HER BLOOD PRESSURE SHOOTING WAY UP HAS RESOLVED. SHE STATES THAT SHE IS AGE (B)(6) RIGHT NOW. CONSUMER REPORTED THAT A FRIEND TOLD HER THE ZINC IN THE SUPER POLIGRIP MAY HAVE CAUSED THIS. CONSUMER REPORTED THAT SHE COULD HAVE BEEN ALLERGIC TO ACID IN THE SUPER POLIGRIP WITH ZINC, UNSPECIFIED DENTURE ADHESIVE WAFERS, FIXODENT OR SEABOND. SHE STATED THAT SHE MAY HAVE BEEN ALLERGIC TO THE ACID IN THE PRODUCTS AND THAT MAY HAVE MADE HER BLOOD PRESSURE INCREASE. CONSUMER REPORTED THAT SHE CANNOT PICK OUT THAT IT WAS DIRECTLY SUPER POLIGRIP CREAM WITH ZINC BECAUSE AT THE TIME, SHE WAS USING OTHER PRODUCTS LIKE WAFERS, FIXODENT AND SEABOND. CONSUMER REFUSED TO PROVIDE THE NAME OF THE HOSPITAL THAT SHE WAS IN. WHEN CONSUMER WAS DISCHARGED FROM THE HOSPITAL, SHE WAS ADVISED BY HER DOCTOR TO LAY DOWN AND NOT GET UP FOR AWHILE. CONSUMER DID REPORT THAT PRIOR TO HER USE OF SUPER POLIGRIP CREAM WITH ZINC THAT HER BLOOD PRESSURE WAS NEVER HIGH AND AFTER SHE DISCONTINUED USING SUPER POLIGRIP WITH ZINC, HER BLOOD PRESSURE WAS NEVER HIGH AGAIN. CONSUMER HASN'T BEEN USING ANYTHING TO HOLD IN HER DENTURE BECAUSE SHE HAS A GOOD FIT BUT SHE DID RECENTLY BUY SUPER POLIGRIP FREE AND SHE IS THINKING THAT SHE MAY START USING THIS AGAIN SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19643 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOO GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization