BEUDAMED
    FDA Adverse Event Other Summary report: N

    FIXODENT DENTURE ADHESIVE, FOOT SEAL, FLAVOR UNK

    MDR report key: 3772060 · Received April 9, 2014

    Report

    Report Number
    1530449-2014-00002
    Event Type
    Other
    Date Received
    April 9, 2014
    Report Date
    March 14, 2014
    Manufacturer
    PROCTER & GAMBLE 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

    GRAND MAL SEIZURE [GRAND MAL CONVULSION]. ITCHING ALL OVER [PRURITUS GENERALISED]. SHORTNESS OF BREATH [DYSPNOEA]. REDNESS FACE [ERYTHEMA]. EYES ALMOST SWELLED SHUT [EYE SWELLING]. SWELLING FACE [SWELLING FACE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT DENTURE ADHESIVE, FOOD SEAL, FLAVOR UNK CREAM, FOR THE FIRST TIME ON HER DENTURES, ONE APPLICATION EARLIER IN THE DAY OF (B)(6) 2004 AND DEVELOPED SYMPTOMS INCLUDING REDNESS FACE, ITCHING ALL OVER AND SOME SHORTNESS OF BREATH AROUND 21:30. THE CONSUMER REMOVED HER DENTURES AT 23:00 ON (B)(6) 2014. THE CONSUMER AWOKE ON (B)(6) 2014 WITH SWELLING OF FACE INCLUDING HER EYES THAT WERE NEARLY SWOLLEN SHUT. THE CONSUMER REPORTED THAT SHE IS UNABLE TO TAKE ANTIHISTAMINES DUE TO HER MEDICAL CONDITIONS AND REGULAR MEDICATIONS. THE CONSUMER REPORTED THAT SHE IS NOT CURRENTLY HAVING BREATHING ISSUES. THE CASE OUTCOME WAS IMPROVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - SALT AND SODIUM COMPOUNDS, DRUG ALLERGY - ASPIRIN, MEDICAL HISTORY - ASTHMA. CONCOMITANT MEDICATIONS INCLUDED: UNSPECIFIED MEDICATIONS. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2014 DRUG AND POISON INFO CENTER FOLLOW-UP CALL: THE CONSUMER REPORTED THAT SHE WENT TO URGENT CARE FOR HER SYMPTOMS AND WHILE SHE WAS THERE SHE HAD A GRAND MAL SEIZURE. THE CONSUMER WOKE UP IN THE HOSPITAL. SHE REPORTED THAT HER FACIAL SWELLING HAD IMPROVED. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS IMPROVED. PAST MEDIAL HISTORY INCLUDED: MEDICAL HISTORY - CONVULSION (HISTORY OF SEIZURES HAS ONE EVERY MONTH), HIST/DRUG/PREV EXP - OTHER MEDICATION (HAS HAD FACIAL SWELLING BEFORE WITH MEDICATIONS). NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214195 FIXODENT DENTURE ADHESIVE, FOOT SEAL, FLAVOR UNK NONE KOO PROCTER & GAMBLE CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other