BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2001138 · Received February 18, 2011

    Report

    Report Number
    1530449-2011-00029
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    February 7, 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]. EXTENSIVE NERVE DAMAGE [NERVE INJURY]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. LOSS OF BALANCE [BALANCE DISORDER]. TINGLING IN HANDS, ARMS, LEGS, AND FEET [PARAESTHESIA]. NUMBNESS IN HANDS, ARMS, LEGS, AND FEET [HYPOAESTHESIA]. ZINC TOXICITY [METAL POISONING]. JOINT AND HIP PAIN [ARTHRALGIA]. DIZZINESS [DIZZINESS]. WEAKNESS [ASTHENIA]. FATIGUE [FATIGUE]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A (B)(6) MALE, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM FROM 2008 THROUGH (B)(6)-2010 AND SUPER POLIGRIP ORIGINAL BEGINNING 2008 TO PRESENT AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, EXTENSIVE NERVE DAMAGE, SEVERE AND PERMANENT PHYSICAL INJURIES, LOSS OF BALANCE, TINGLING IN HANDS, ARMS, LEGS, AND FEET, NUMBNESS IN HANDS, LEGS AND FEET, ZINC TOXICITY, JOINT AND HIP PAIN, DIZZINESS, WEAKNESS, AND FATIGUE. TREATMENT: 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 77 YR Disability