BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    MDR report key: 2011707 · Received March 3, 2011

    Report

    Report Number
    1530449-2011-00045
    Event Type
    Other
    Date Received
    March 3, 2011
    Report Date
    February 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OR PRODUCT NOT PROVIDED; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. HYPOCUPREMIA [COPPER DEFICIENCY]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. FATIGUE [FATIGUE]. DIGESTIVE ISSUES [DYSPEPSIA]. TINGLING [PARAESTHESIA]. NUMBNESS [HYPOAESTHESIA]. PAIN [PAIN]. WEAKNESS OF HANDS, ARMS, FEET AND LEGS [MUSCULAR WEAKNESS]. LOSS OF CONTROL FEET AND LEGS [LOSS OF CONTROL OF LEGS]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. LOSS OF CONTROL OF HANDS AND ARMS [MUSCULOSKELETAL DISORDER]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT MALE CLIENT , NOW (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM AND/OR SUPER POLIGRIP DENTURE ADHESIVE, UNSPECIFIED TOTAL DAILY USES BEGINNING 1995 TO PRESENT, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, EXTENSIVE NERVE DAMAGE RESULTING IN FATIGUE, DIGESTIVE ISSUES, TINGLING, NUMBNESS, PAIN, WEAKNESS AND LOSS OF CONTROL OF HANDS, ARMS, FEET, AND LEGS. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. 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 UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE NONE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability