BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2470696 · Received February 24, 2012

    Report

    Report Number
    1530449-2012-00006
    Event Type
    Other
    Date Received
    February 24, 2012
    Report Date
    September 9, 2011
    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 AND CASE CONCERNS LONG-TERM PRODUCT USE.

    Description of Event or Problem · 1

    PERMANENT DISFIGUREMENT [DEFORMITY]. TOXICITY POISONING [POISONING]. MENTAL IMPAIRMENT [MENTAL IMPAIRMENT]. PHYSICAL INJURIES [INJURY]. PHYSICIAN PAIN [PAIN]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK AND REPORTED THE FOLLOWING: INJURIES. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. CONCOMITANT MEDICATIONS INCLUDED: EFFERDENT. NO FURTHER INFO WAS PROVIDED. ON 2/10/2012 SAFETY RECEIVED LEGAL DOCUMENTS WHICH REVEALED: THE CONSUMER BEGAN EXPERIENCING TOXICITY POISONING ON OR AROUND (B)(6) 2008. ADD'L EVENTS WERE REPORTED: PERMANENT DISFIGUREMENT, MENTAL IMPAIRMENT, PHYSICAL INJURIES, AND PHYSICAL PAIN. TREATMENT: UNSPECIFIED MEDICAL TREATMENT. THE OUTCOME WAS NOT RECOVERED/NOT RESOLVED FOR ALL EVENTS. 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%, C DENTURE ADHESIVE KOO PROCTER & GAMBLE MFG CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability