BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2093693 · Received April 21, 2011

    Report

    Report Number
    1530449-2011-00074
    Event Type
    Other
    Date Received
    April 21, 2011
    Report Date
    February 9, 2011
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Description of Event or Problem · 1

    NEURO/MUSCULAR CONDITIONS [NEUROMYOPATHY]. WALK WITH A WALKER [MOBILITY DECREASED]. MUSCLE DISEASE [MUSCLE DISORDER]. ANEURYSM [ANEURYSM]. FALLEN [FALL]. CUT HEAD OPEN [SKIN LACERATION]. HURTING, PAIN [PAIN]. WEAKNESS [ASTHENIA]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN DAILY FOR 10 YEARS BEGINNING 2001 AND REPORTED THE FOLLOWING: HAS HAD SOME NEURO/MUSCULAR CONDITIONS FOR MANY YEARS, WALKS WITH A WALKER, WAS FOUND TO HAVE A MUSCLE DISEASE IN 2003, HAD AN ANEURYSM, HAS FALLEN AND CUT HER HEAD OPEN, IS HURTING AND IN PAIN, AND EXPERIENCING WEAKNESS. THE CONSUMER HAS CONSULTED HER PHYSICIAN BUT NOT DISCUSSED HER USE OF FIXODENT. TREATMENT: MANY UNSPECIFIED MEDICATIONS. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2011 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT OF (B)(6) 2011: THE CONSUMER, AGE (B)(6), REPORTED THAT HER PHYSICIANS HAVE PRESCRIBED MUSCLE RELAXERS TO TREAT THE SYMPTOMS. NO FURTHER INFORMATION 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 PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability