BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1943822 · Received December 22, 2010

    Report

    Report Number
    1530449-2010-00143
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    January 1, 2006
    Report Date
    December 1, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISTORTION IN SENSE OF TASTE, LOSS OF ABILITY TO IDENTIFY TASTES [AGEUSIA] DISTORTION IN SENSE OF SMELL, LOSS OF ABILITY TO IDENTIFY SMELLS [ANOSMIA] NEUROPATHY [NEUROPATHY PERIPHERAL] AFFECTED ABILITY TO STAND FOR LONG PERIODS OF TIME [DYSSTASIA] TINGLING SENSATION OF FEET [PARAESTHESIA] NUMBNESS OF FEET [HYPOAESTHESIA] POST NASAL DRIP [UPPER-AIRWAY COUGH SYNDROME] STOMACH PROBLEMS [GASTRIC DISORDER] TROUBLE WITH VOICE, LARYNGITIS-LIKE PROBLEMS, VOICE WOULD GO OUT AFTER 3-5 HOURS [APHONIA] MAKING FEEL ILL MUCH OF THE TIME [MALAISE] CASE DESCRIPTION: A REGULATORY AUTHORITY REPRESENTATIVE REPORTED THAT THEY WERE NOTIFIED THAT A MALE CONSUMER, AGE UNSPECIFIED, BEGAN USING FIXODENT DENTURE ADHESIVE ORIGINAL CREAM, FIXODENT DENTURE ADHESIVE COMPLETE MULTICARE, AND POLIGRIP DENTURE ADHESIVE CREAM (ONCE OR TWICE), TO SECURE A TEMPORARY PARTIAL THAT WAS NO LONGER STABLE A COUPLE OF MONTHS AFTER RECEIVING IT IN 1998, AND REPORTED THE FOLLOWING: NOTICE A DISTORTION IN SENSE OF TASTE, LOSS OF ABILITY TO IDENTIFY TASTES AND A DISTORTION IN SENSE OF SMELL, LOSS OF ABILITY TO IDENTIFY SMELLS IN 2006, DEVELOPED POST NASAL DRIP AND RESULTING STOMACH PROBLEMS CAUSING HIM TO FEEL ILL MUCH OF THE TIME, EXPERIENCED TROUBLE WITH VOICE, LARYNGITIS-LIKE PROBLEMS OVER THE LAST FEW YEARS, VOICE WOULD GO OUT AFTER 3-5 HOURS, AND NOTICED A TINGLING SENSATION AND NUMBNESS MORE SO IN THE MIDDLE TOES OF HIS LEFT FOOT IN EARLY 2000'S. EVENTUALLY BECOMING PRESENT TO A LESSER DEGREE IN RIGHT FOOT, WAS DIAGNOSED WITH NEUROPATHY AFFECTING HIS ABILITY TO STAND FOR LONG PERIODS OF TIME AND QUALIFYING HIM TO RECEIVE DISABILITY. THE CONSUMER VISITED HIS PHYSICIAN SOME LENGTH OF TIME AFTER FIRST NOTING THE SYMPTOMS OF TINGLING AND NUMBNESS; HE BECAME CONCERNED THAT HE HAD CIRCULATION ISSUES AND WHEN THAT WAS NOT THE CASE, WAS REFERRED TO A FOOT DOCTOR (NOT SEEN). THE CONSUMER'S PRIMARY PHYSICIAN DIAGNOSED NEUROPATHY AND LATER ORDERED AN MRI TO DETERMINE WHAT WAS AFFECTING HIS SENSE OF SMELL. TREATMENT: ENT SURGICALLY CORRECTED A DEVIATED SEPTUM WHICH PARTIALLY REDUCED THE PROBLEM OF ODOR UPON BREATHING BUT DID NOT ALLEVIATE THE LOSS OF ABILITY TO IDENTIFY SMELLS AND TASTES; TRIED SPEECH THERAPY TO TREAT TROUBLE WITH VOICE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - RECEIVED A TEMPORARY PARTIAL IN 1998 AND CONTINUED TO WEAR IT INSTEAD OF HAVING DENTAL IMPLANTS, NASAL DEVIATED SEPTUM. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability