BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK (CALCIUM ZINC GANTREZ SALT 33-59%,

    MDR report key: 1696219 · Received May 19, 2010

    Report

    Report Number
    1530449-2010-00076
    Event Type
    Other
    Date Received
    May 19, 2010
    Report Date
    May 4, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. PMA/510(K) # K945200.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. EXCESS ZINC [BLOOD ZINC INCREASED]. PROFOUND AND PERMANENT INJURIES [INJURY]. COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN AND SUPER POLIGRIP, INTERCHANGEABLY BEGINNING IN 2006 THROUGH 2009 AS HER DENTURE ADHESIVES OF CHOICE AND REPORTED THE FOLLOWING: EXCESS ZINC, RESULTING IN COPPER DEPLETION, PROFOUND AND PERMANENT NEUROLOGICAL AND OTHER INJURIES. THE CONSUMER IS UNABLE TO PERFORM HER NORMAL CUSTOMARY AND DAILY ACTIVITIES AND REQUIRES CONSTANT CARE AND ASSISTANCE. THE CASE OUTCOME WAS NOT RECOVERED/NO 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, FORM/VERSION UNK (CALCIUM ZINC GANTREZ SALT 33-59%, DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability