BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2519792 · Received March 29, 2012

    Report

    Report Number
    1530449-2012-00016
    Event Type
    Other
    Date Received
    March 29, 2012
    Report Date
    March 21, 2012
    Manufacturer
    PROCTOR AND GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    (US) OTC DEV
    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. ADD'L 510K #K945200.

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES, OTHER INJURIES [INJURY]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. HYPOCUPREMIA [COPPER DEFICIENCY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR (B)(6) FEMALE CLIENT USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK AS INTENDED FOR HER DENTURES, THAT SHE RECEIVED APPROXIMATELY 15 YEARS AGO, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES; HAS BEEN DIAGNOSED WITH OTHER INJURIES ATTRIBUTED TO EXCESS ZINC AND RESULTING COPPER DEPLETION, AND HYPOCUPREMIA. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDIAL CARE. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. SHE HAD DISCONTINUED USE OF THE PRODUCT. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - RECEIVED DENTURES APPROX 15 YEARS AGO. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59 DENTURE ADHESIVE KOO PROCTOR AND GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability