BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (FORMULATION UNKNOWN)

    MDR report key: 1981209 · Received January 28, 2011

    Report

    Report Number
    9681138-2011-00023
    Event Type
    Other
    Date Received
    January 28, 2011
    Report Date
    January 26, 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 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 HEADACHE IN A (B)(6) MALE PT WHO RECEIVED (SUPER POLIGRIP (UNK FORMULATION CONTAINING ZINC) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED FLUOXETINE HYDROCHLORIDE (PROZAC). IN 2009, THE PT UNDERWENT SUCCESSFUL SURGERY TO CORRECT A SHORT CIRCUIT IN HIS HEART THAT CAUSED HIS HEART TO RACE. ON AN UNK DATE IN (B)(6) 2010, THE PT STARTED SUPER POLIGRIP WITH ZINC. AROUND (B)(6) 2010, HE HAD HEADACHES AND MIGRAINE RESULTING IN THE CONSUMER GOING TO THE ER ON 3 OCCASIONS. THE PT UNDERWENT UNSPECIFIED BLOOD TESTS AND WAS TREATED WITH INTRAVENOUS DIPHENHYDRAMINE HC1 (BENADRYL) AND INTRAVENOUS PAIN MEDICATION (UNSPECIFIED). THE CONSUMER WAS NOT ADMITTED TO THE HOSP. HE REPORTED THAT ON (B)(6) 2011, HE WAS DRIVING HIS WORK VEHICLE, PASSED OUT THEN HIT A BRIDGE. HE REPORTED THAT HE PASSED OUT DUE TO LOW BLOOD PRESSURE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. HE REPORTED THAT HE CARED FOR HIS VEHICLE, THEN LATER THAT DAY, HE WENT TO HIS DOCTOR. HE REPORTED THAT WAS TOLD THAT HE HAD LOW BLOOD PRESSURE, WAS SENT DIRECTLY TO A CARDIOLOGIST'S OFFICE WHERE HE WAS GIVEN A HEART MONITOR TO WEAR FOR 24 HOURS. THE RESULTS OF THE HEART MONITOR WERE REPORTED AS "OKAY". THE PT REPORTED THAT HE LOST WEIGHT WHILE USING SUPER POLIGRIP CONTAINING ZINC. IN (B)(6) 2010, HIS WEIGHT WAS (B)(6) POUNDS. ON (B)(6) 2011, AFTER USING SUPER POLIGRIP CONTAINING ZINC, HIS WEIGHT WAS DOWN TO (B)(6) LBS. IN (B)(6) 2011, WITHIN (B)(6) OF HIS MOTOR VEHICLE ACCIDENT, SUPER POLIGRIP WAS DISCONTINUED DUE TO A MIGRAINE AND VOMITING. WITHIN ONE DAY OF DISCONTINUATION OF SUPER POLIGRIP CONTAINING ZINC, THE PT WAS "FINE IN ONE DAY". AT AN UNK TIME AFTER DISCONTINUING SUPER POLIGRIP CONTAINING ZINC, HIS WEIGHT HAD INCREASED TO (B)(6) LBS. THE PT REPORTED THAT IN (B)(6) 2011, "(B)(6) AFTER (B)(6) 2011" HE HAD A BLOOD TEST FOR POSSIBLE "ZINC POISONING" AND HE HAS NOT RECEIVED THE RESULTS AT TIME OF REPORTING. HE STATED THAT HIS DR TOLD HIM THAT USE OF SUPER POLIGRIP CAUSED HIM TO HAVE ZINC POISONING. AT THE TIME OF REPORTING, THE OUTCOME OF POSSIBLE METAL POISONING WAS UNK, THE WEIGHT LOSS HAD IMPROVED, WHILE THE REMAINING EVENTS WERE RESOLVED. THE PT SAID THAT HE SWITCHED TO A ZINC-FREE FORMULATION OF SUPER POLIGRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FORMULATION UNKNOWN) DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other FLUOXETINE HYDROCHLORIDE