BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1993314 · Received February 4, 2011

    Report

    Report Number
    1530449-2011-00016
    Event Type
    Other
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2007
    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

    NEUROLOGICAL SYMPTOMS [NEUROLOGICAL SYMPTOM]. BURNING SENSATIONS [BURNING SENSATION]. NUMBNESS IN TOES AND BOTTOMS OF FEET [HYPOAESTHESIA]. SHOOTING PAINS ACROSS SHOULDERS [MUSCULOSKELETAL PAIN]. GENERAL AND SHOOTING PAINS THROUGH HANDS AND LEGS [PAIN IN EXTREMITY]. UNABLE TO WALK MORE THAN A FEW METERS WITHOUT HAVING LEGS LOCK UP [ABASIA]. BALANCE PROBLEMS [BALANCE DISORDER]. PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THEIR ADULT MALE CLIENT, AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM 1 APPLIC, 1-2 TIMES A DAY AND POLIGRIP DENTURE ADHESIVE CREAM 1 APPLIC, 1-2 A DAY BEGINNING IN 2001, INITIALLY USING POLIGRIP THEN SWITCHING TO FIXODENT, AND REPORTED THE FOLLOWING: NEUROLOGICAL SYMPTOMS BEGINNING IN 2007, BURNING SENSATIONS, NUMBNESS IN TOES AND BOTTOMS OF FEET, SHOOTING PAINS ACROSS SHOULDERS, GENERAL AND SHOOTING PAINS THROUGH HANDS AND LEGS, UNABLE TO WALK MORE THAN A FEW METERS WITHOUT HAVING LEGS LOCK UP, BALANCE PROBLEMS, AND PHYSICAL INJURIES. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED MEDICAL TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. HE DISCONTINUED USE OF THE PRODUCTS IN 2009. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability