BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1943587 · Received December 13, 2010

    Report

    Report Number
    1530449-2010-00133
    Event Type
    Other
    Date Received
    December 13, 2010
    Report Date
    November 17, 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
    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 SYS DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. NEUROPATHY [NEUROPATHY PERIPHERAL]. EXCESS ZINC [BLOOD ZINC INCREASED]. RESULTING IN COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, AN ADULT FEMALE WHO IS NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK, CREAM AS HER DENTURE ADHESIVE OF CHOICE ON UPPER DENTURES RECEIVED IN 1981 AND BOTTOM DENTURES RECEIVED IN 1989, WITH LAST KNOWN USE IN (B)(6) 2010, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, WAS DIAGNOSED WITH NEUROPATHY IN (B)(6) 2010 ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION, AND HAS SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER. 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 %, CELL DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability