BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1993311 · Received February 4, 2011

    Report

    Report Number
    1530449-2011-00020
    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

    PARALYSIS ON THE LEFT SIDE OF BODY [HEMIPLEGIA]. SEVERE NEUROLOGICAL SYMPTOMS [NEUROLOGICAL SYMPTOM]. PAIN IN HANDS AND FEET [PAIN IN EXTREMITY]. TREMORS IN HANDS AND FEET [TREMOR]. SEVERE BURNING SENSATIONS IN HANDS AND FEET [BURNING SENSATION]. TINGLING IN HANDS AND FEET [PARAESTHESIA]. NUMBNESS OF HANDS AND FEET [HYPOAESTHESIA]. WEAKNESS ON THE LEFT SIDE OF BODY [HEMIPARESIS]. STIFFNESS IN LEGS [MUSCULOSKELETAL STIFFNESS]. ALMOST IMPOSSIBLE TO WALK, DEVELOPED AN UNUSUAL GAIT [GAIT DISTURBANCE]. SPEECH PROBLEMS [SPEECH DISORDER]. NEUROPATHY [NEUROPATHY PERIPHERAL]. PERIPHERAL NERVE DAMAGE [NERVE INJURY]. PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT FEMALE CLIENT, AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM WHEN SHE FIRST REQUIRED DENTURES IN 2004 AND USED POLIGRIP DENTURE ADHESIVE, UNSPECIFIED TOTAL DAILY USE, AND REPORTED THE FOLLOWING: BEGAN TO EXPERIENCE SEVERE NEUROLOGICAL SYMPTOMS IN 2007, PAIN AND SEVERE BURNING SENSATIONS IN HANDS AND FEET, TREMORS IN HANDS AND FEET, TINGLING AND NUMBNESS IN HANDS AND FEET, WEAKNESS AND PARALYSIS ON THE LEFT SIDE OF HER BODY, EXPERIENCED STIFFNESS IN LEGS MAKING IT ALMOST IMPOSSIBLE TO WALK AND DEVELOPED AN UNUSUAL GAIT, PHYSICAL INJURIES, DEVELOPED SPEECH PROBLEMS AND IS UNABLE TO ADEQUATELY EXPRESS HERSELF, CONDITION WAS DIAGNOSED AS NEUROPATHY AND PERIPHERAL NERVE DAMAGE. PROCEDURES INCLUDED A SPINAL TAP AND SEVERAL BRAIN EXAMS. TREATMENT: MANY MONTHS OF REHABILITATION, WAS TREATED IN THE NEUROLOGY DEPARTMENT FOR BRAIN THERAPY AND PHYSIOTHERAPY; IS CURRENTLY TAKING UNSPECIFIED MEDICATION TO TREAT HER CONDITION. THE CONSUMER RECOMMENDED WORK ON A GRADUAL BASIS BUT ANTICIPATES FUTURE MEDICAL TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - FIRST REQUIRED DENTURES IN 2004. 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%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability