BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1622872 · Received March 3, 2010

    Report

    Report Number
    1530449-2010-00006
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    January 1, 2009
    Report Date
    February 19, 2010
    Manufacturer
    PROCTER & GAMBLE MFG CO.
    Product Code
    KOO
    PMA / PMN Number
    945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF PRODUCT WAS NOT PROVIDED BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    NEUROPATHY (PROVISIONAL DIAGNOSIS) [NEUROPATHY PERIPHERAL]. DIAGNOSED WITH EXCESS ZINC [HYPERZINCAEMIA]. COPPER DEPLETION [COPPER DEFICIENCY]. PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NEUROLOGICAL COMPLICATION FROM DEVICE]. PROFOUND AND PERMANENT INJURIES/PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT FEMALE AGE (B)(6), USED (AND INGESTED) FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM OR SUPER POLIGRIP DENTURE ADHESIVE CREAM SINCE RECEIVING DENTURE APPROX 16 YEARS AGO, IN 1993, LAST KNOWN USE IN 2009, AND HAS SUFFERED FROM PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, PROFOUND AND PERMANENT INJURIES/PHYSICAL INJURIES, AND WAS DIAGNOSED WITH NEUROPATHY ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION IN 2009. SHE HAS REC'D AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. BECAUSE OF THE EVENTS, THE CLIENT HAD DISABILITIES AND WAS UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. 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 UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability