BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1884156 · Received October 14, 2010

    Report

    Report Number
    1530449-2010-00121
    Event Type
    Other
    Date Received
    October 14, 2010
    Report Date
    October 6, 2010
    Manufacturer
    PROCTER & GAMBLE MFG. CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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/NEUROLOGICAL DAMAGE (NERVOUS SYSTEM DISORDER), ZINC TOXICITY (METAL POISONING), CHRONIC PAIN IN BOTH LEGS (PAIN IN EXTREMITY), FINGER NUMBNESS (HYPOESTHESIA), FOOT SPASMS (MUSCLE SPASMS), SEVERE AND PERMANENT PHYSICAL INJURIES (INJURY), COPPER DEPLETION (BLOOD COPPER DECREASED). CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM BEGINNING 1993 TO PRESENT CONCURRENTLY WITH SUPER POLIGRIP BEGINNING 2000 THROUGH (B)(6) 2010, FOR HER PERSONAL USE AS DENTAL ADHESIVES, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES/NEUROLOGICAL DAMAGE THAT INCLUDED CHRONIC PAIN IN BOTH LEGS, FINGER NUMBNESS, AND FOOT SPASMS, ZINC TOXICITY, COPPER DEPLETION, AND SEVERE AND PERMANENT PHYSICAL INJURIES. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED, NOT RESOLVED. 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 DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG. CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability