BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, VERSION UNK

    MDR report key: 4170714 · Received October 14, 2014

    Report

    Report Number
    1530449-2014-00006
    Event Type
    Other
    Date Received
    October 14, 2014
    Report Date
    September 16, 2014
    Manufacturer
    PROCTER & GAMBLE 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 AND CASE CONCERNS LONG TERM USE OF THE PRODUCT.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. MYELOPATHY [MYELOPATHY]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. COPPER DEPLETION, COPPER DEFICIENCY [COPPER DEFICIENCY]. EXCESS ZINC [HYPERZINCAEMIA]. ZINC POISONING [METAL POISONING]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR FEMALE CLIENT, NOW AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK, UNSPECIFIED TOTAL DAILY USE AS INTENDED TO HOLD DENTURES THAT SHE RECEIVED APPROX 20 YEARS AGO BEGINNING 1994 THROUGH (B)(6) 2013 AND REPORTED THE FOLLOWING: DIAGNOSED WITH MYELOPATHY ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION IN (B)(6) 2013; PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, ZINC POISONING AND COPPER DEFICIENCY. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER (RECEIVED DENTURES APPROX 20 YEARS AGO). NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649570 FIXODENT DENTURE ADHESIVE, VERSION UNK DENTURE ADHESIVE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other