BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2001139 · Received February 18, 2011

    Report

    Report Number
    1530449-2011-00030
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    February 11, 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 WAS NOT PROVIDED BY THE REPORTER 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]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. HYPOCUPREMIA [COPPER DEFICIENCY]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. LOSS OF BALANCE [BALANCE DISORDER]. WEAKNESS OF LEGS AND ARMS [MUSCULAR WEAKNESS]. TINGLING OF LEGS AND ARMS [PARESTHESIA]. PAIN IN LEGS AND ARMS [PAIN IN EXTREMITY]. CONSTIPATION [CONSTIPATION]. NUMBNESS IN LEGS AND ARMS [HYPOAESTHESIA]. BLADDER DYSFUNCTION [BLADDER DYSFUNCTION]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR ADULT MALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM CONCURRENTLY WITH SUPER POLIGRIP DENTURE ADHESIVE, UNSPECIFIED TOTAL DAILY USES 1993 TO PRESENT AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES, HYPOCUPREMIA, EXTENSIVE NERVE DAMAGE RESULTING IN LOSS OF BALANCE, WEAKNESS IN LEGS AND ARMS, TINGLING IN LEGS AND ARMS, NUMBNESS IN LEGS AND ARMS, AND PAIN IN LEGS AND ARMS, CONSTIPATION AND BLADDER DYSFUNCTION. 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 UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability