BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1812574 · Received August 16, 2010

    Report

    Report Number
    1530449-2010-00108
    Event Type
    Other
    Date Received
    August 16, 2010
    Report Date
    July 30, 2010
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]; NEUROPATHY [NEUROPATHY PERIPHERAL]; SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]; EXCESS ZINC [BLOOD ZINC INCREASED]; COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM AND SUPER POLIGRIP, AS HER DENTURE ADHESIVES OF CHOICE AND REPORTED THE FOLLOWING: DIAGNOSED WITH NEUROPATHY IN 2009; PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; SEVERE AND PERMANENT PHYSICAL INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES; EXCESS ZINC AND COPPER DEPLETION CONFIRMED BY LAB TESTS WITHIN THE PAST YEAR. SHE HAS AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. HEALTH CARE PROFESSIONALS HAVE BEEN VISITED. TREATMENT CONSISTED OF 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%, CELLU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability FREQUENCY & ROUTE USED: INTRAORAL| SUPER POLIGRIP, DOSE: UNK,| ADHESIVE PROD OF CHOICE (DENTURE WEARER)| DIAGNOSIS FOR USE: DENTURE WEARER AND DENTURE