BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESVIE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 2089811 · Received April 11, 2011

    Report

    Report Number
    1530449-2011-00073
    Event Type
    Other
    Date Received
    April 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    BALANCE PROBLEM, USES CANE [BALANCE DISORDER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT MALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, ORIGINAL CREAM 1 APPLICATION, 1 - 2/DAY FOR HIS PARTIAL AND REPORTED THE FOLLOWING: HAVE HAD A BALANCE PROBLEM FOR SOME TIME, EXPERIENCE PAIN. THE CONSUMER WAS ADMITTED TO THE HOSP WHERE HE HAD BACK SURGERY THAT HAS HELPED RELIEVE THE PAIN. TREATMENT: PHYSICAL THERAPY. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. CONCOMITANT MEDICATIONS INCLUDED: CARDIAC THERAPY TO TREAT HEART, ATRIAL FIBRILLATION, CHOLESTEROL - AND TRIGLYCERIDE REDUCERS. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2011 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT OF (B)(6) 2011: THE CONSUMER, (B)(6) YEARS, REPORTED THAT HE HAS HAD A PARTIAL FOR YEARS AND YEARS BUT HAS ONLY BEEN USING FIXODENT TO KEEP IT IN PLACE SINCE THE LITTLE HOOKS BROKE OFF. HE WASN'T SURE THE BALANCE PROBLEM IN HIS LEGS IS RELATED TO HIS USE OF FIXODENT BUT HE HAS HAD PHYSICAL THERAPY OR WORKOUTS AT A LOCAL FITNESS CLUB TO STRENGTHEN HIS LEGS AND STILL HAS TO CARRY A CANE AROUND. HE HAD VISITED THE NEUROSURGEON TO SEE IF SOMETHING ELSE MIGHT BE CONTRIBUTING TO THE BACK PAIN HE HAS EXPERIENCED. THE CONSUMER HAS NO ALLERGIES AND TAKES LIPITOR FOR CHOLESTEROL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESVIE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other CARDIAC THERAPY| LIPITOR (ATORVASTATIN CALCIUM)