BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU

    MDR report key: 1651931 · Received April 5, 2010

    Report

    Report Number
    1530449-2010-00021
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    January 12, 2009
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    (US)OTC DEVI
    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. PMA/510(K) # K945200.

    Description of Event or Problem · 1

    NEUROPATHY [NEUROPATHY PERIPHERAL], HANDICAPPED, IN A WHEELCHAIR [DISABILITY], QUADRAPLEGIC [QUADRIPLEGIA], FACE LOOKS LIKE IT HAS BRUISES ON IT [CONTUSION], FIBROMYALGIA [FIBROMYALGIA], ENTIRE BODY IS BROKE OUT [DERMATITIS], TINGLING IN FEET [PARAESTHESIA], NUMBNESS FEET AND HANDS, LEGS ALWAYS NUMB [HYPOAESTHESIA], PASSING OUT [LOSS OF CONSCIOUSNESS], MEMORY LOSS [AMNESIA], MOUTH RASH [RASH], MOUTH BREAKING OPEN [STOMATITIS], FEELING YUCKY/JUST OUT OF IT [FEELING ABNORMAL], TEST SHOWED A WEAKNESS TO FIXODENT [INVESTIGATION ABNORMAL], WHEN GRAZING FINGERS OVER SKIN, COULD ONLY FEEL HALF SENSATION [PARAESTHESIA]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, A FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK SINCE SHE WAS (B)(6) OF AGE AND REPORTED THE FOLLOWING: NEUROPATHY, FACE LOOKS LIKE IT HAS BRUISES ON IT, FIBROMYALGIA, ENTIRE BODY IS BROKE OUT, TINGLING IN FEET, HANDICAPPED - IN A WHEEL CHAIR NOW. SHE STATED THAT HER PHYSICIANS DID NOT KNOW THE CAUSE OF HER SYMPTOMS. TREATMENT: NOT SPECIFIED. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2009 UPDATE: DETAILS REVEALED IN A REVIEW OF THE INITIAL CONTACT OF (B)(6) 2009: THE CONSUMER REPORTED THAT SHE USED FIXODENT DENTURE ADHESIVE ORIGINAL CONCURRENTLY WITH FIXODENT DENTURE ADHESIVE FREE AND POLIGRIP; CONCOMITANT MEDICATIONS INCLUDED: "BLOOD PRESSURE PILL" AND "DIZZY PILL." ADD'L SYMPTOMS REPORTED: QUADRAPLEGIC, NUMBNESS IN FEET AND HANDS, LEGS ALWAYS NUMB, PASSING OUT, MEMORY LOSS, MOUTH RASH, MOUTH BREAKING OPEN, FEELING YUCKY/JUST OUT OF IT, WEAKNESS TO FIXODENT, IN A WHEELCHAIR, AND WHEN GRAZING FINGERS OVER SKIN, COULD ONLY FEEL HALF SENSATION. THE CONSUMER STATED THAT A KINESIOLOGY TEST BY A CHIROPRACTOR REVEALED WEAKNESS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE ADHESIVE, ORIGINAL (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE GU DENTURE ADHESIVE KOO PROCTER & GAMBLE MANUFACTURING CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability "BLOOD PRESSURE PILL"| "DIZZY PILL"