BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33% CELLUL

    MDR report key: 1993332 · Received February 4, 2011

    Report

    Report Number
    1530449-2011-00021
    Event Type
    Other
    Date Received
    February 4, 2011
    Report Date
    January 14, 2011
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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

    NEUROPATHY [NEUROPATHY PERIPHERAL], SEVERE HEADACHES [HEADACHE], INSOMNIA [INSOMNIA], VERY LOW ENERGY LEVEL [ASTHENIA], DAILY DIARRHEA [DIARRHEA], STOMACH PAIN [ABDOMINAL PAIN UPPER], ANEMIA [ANEMIA], GENERAL FEELING OF UNWELLNESS [MALAISE], SUSCEPTIBILITY TO COLDS [INFECTION SUSCEPTIBILITY INCREASED], (PAINFUL) PINS AND NEEDLES IN ARMS, LEGS AND FEET [PARESTHESIA], SHARP NERVE PAIN [NEURALGIA], NUMBNESS IN LEGS AND FEET [HYPOAESTHESIA], DIZZINESS [DIZZINESS], UNABLE TO WALK FAR DISTANCES AND CANNOT WALK PROPERLY [GAIT DISTURBANCE], UNSTEADINESS [BALANCE DISORDER], HAS FALLEN DOWN STAIRS [FALL], PAIN IN ARMS [PAIN IN EXTREMITY], SHAKING IN ARMS [TREMOR], OCCASIONALLY LOSES CONTROL OF ARMS [MUSCULOSKELETAL DISORDER], DRUG EXPOSURE DURING PREGNANCY (ADULT USED FIXODENT/POLIGRIP DENTURE ADHESIVES WHILE PREGNANT)[DRUG EXPOSURE DURING PREGNANCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM WHEN THE PRODUCT SHE USED MAINLY SINCE 1989, POLIGRIP DENTURE ADHESIVE, WAS NOT AVAILABLE; UNSPECIFIED TOTAL DAILY USE OF THE DENTURE ADHESIVES UNTIL (B)(6) 2010, INCLUDING DURING PREGNANCY, AND REPORTED THE FOLLOWING: HAS BEEN DIAGNOSED WITH NEUROPATHY BY SEVERAL DOCTORS AND SPECIALIST; IN OR AROUND 1993 BEGAN TO EXPERIENCE SEVERE HEADACHES, INSOMNIA, VERY LOW ENERGY LEVEL, DAILY DIARRHEA, STOMACH PAIN, ANEMIA, A GENERAL FEELING OF UNWELLNESS, AND A SUSCEPTIBILITY TO COLDS; IN OR AROUND 1996 BEGAN TO EXPERIENCE NUMBNESS AND PINS AND NEEDLES IN HER LEGS AND FEET THAT GRADUALLY GREW WORSE OVER TIME, NOW IS UNABLE TO WALK FAR DISTANCES AND CANNOT WALK PROPERLY, HAS FALLEN DOWN STAIRS SEVERAL TIMES, OCCASIONALLY GETS SHARP NERVE PAIN THAT RENDERS HER UNABLE TO SIT OR STAND FOR EXTENDED PERIODS OF TIME; IN OR AROUND (B)(6) 2010, BEGAN TO EXPERIENCE PAINFUL PINS AND NEEDLES AND SHAKING IN HER ARMS, OCCASIONALLY LOSES CONTROL OF HER ARMS, EXPERIENCES BOUTS OF DIZZINESS AND UNSTEADINESS; DRUG EXPOSURE DURING PREGNANCY (ADULT USED FIXODENT/POLIGRIP DENTURE ADHESIVES WHILE PREGNANT). THE CONSUMER DISCONTINUED USE OF DENTURE ADHESIVES CONTAINING ZINC IN (B)(6) 2010. HER SYMPTOMS HAVE INCREASED IN SEVERITY IN THE PAST 5 YEARS AND SHE HAS BEEN BEDRIDDEN THE LAST 2 YEARS. TREATMENT: HAS TAKEN AND IS CURRENTLY TAKING SEVERAL UNSPECIFIED MEDICATIONS, GOES TO UNSPECIFIED APPOINTMENTS AND TREATMENTS; ANTICIPATES FUTURE MEDICAL TREATMENTS. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability