BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT PLUS SCOPE DENTURE CLEANSER (POTASSIUM MONOPERSULFATE 0.868 G, SODIUM P

    MDR report key: 2926138 · Received January 17, 2013

    Report

    Report Number
    9617667-2013-00001
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    PROCTER & GAMBLE MFG. GMBH
    Product Code
    EFT
    PMA / PMN Number
    K845200
    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; UNABLE TO PROCEED WITH PRODUCT INVESTIGATION, CONSUMER HAD DISCARDED THE PRODUCT.

    Description of Event or Problem · 1

    ALLERGIC REACTION [ALLERGIC REACTION]. DIFFICULTY BREATHING [DIFFICULTY BREATHING]. TONGUE STARTED SWELLING [SWELLING OF TONGUE]. MOUTH STARTED SWELLING [SWOLLEN MOUTH]. TONGUE FEELS THICK [TONGUE THICK]. SWELLING ON ARMS AND LEGS [SWELLING ARM]. HARD KNOT UNDERNEATH ABOVE BELLY BUTTON [GASTRIC DISORDER]. SWOLLEN LIP [SWOLLEN LIPS]. WELTS ON ARM, ARMPITS, LEG (BROKE OUT IN HIVES) [WELTS]. ITCHING - BODY [ITCHING ALL OVER]. CASE DESCRIPTION: A CONSUMER REPORTED THAT THEY, AN ADULT FEMALE AGE UNSPECIFIED, USED FIXODENT PLUS SCOPE DENTURE CLEANSER TABLET, A TOTAL OF 3 TABLETS, LAST KNOWN USE ON (B)(6) 2012, AND REPORTED THE FOLLOWING: LIP IS SWOLLEN ON THE RIGHT SIDE, HER TONGUE FEELS THICK, HAS DEVELOPED SWELLING AND WELTS ON HER ARMS, UNDERNEATH BOTH ARMS AND ARMPITS, HAS WELTS ON THE BACK OF HER LEG, AND IS EXPERIENCING ITCHING - BODY. TREATMENT: 2 BENADRYL. THE CASE OUTCOME WAS NOT RECOVERED/RESOLVED. PAST MEDICAL HISTORY INCLUDED: ALLERGY - POLLEN, HAY FEVER. MEDICAL HISTORY - BIPOLAR, CONCOMITANT MEDICATIONS INCLUDED: "BIPOLAR MEDICATION". NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2012: DRUG AND POISON INFO CENTER F/U PHONE CALL: THE CONSUMER'S HUSBAND REPORTED THAT HIS WIFE HAS BEEN IN THE HOSPITAL FOR 2 DAYS AND IS BEING TREATED FOR AN ALLERGIC REACTION. HE STATED THAT HIS WIFE WAS DOING BETTER. NO FURTHER INFO WAS PROVIDED. ON (B)(6) 2013: SAFETY F/U PHONE CALL TO CONSUMER: THE CONSUMER REPORTED THAT SHE HAD EXPERIENCED ADD'L SYMPTOMS OF DIFFICULTY BREATHING, HIVES, AND HER MOUTH AND TONGUE STARTED SWELLING BEFORE BEING TAKEN TO THE HOSPITAL BY AMBULANCE. SHE WAS GIVEN OXYGEN AND UNSPECIFIED MEDICATIONS FOR AN ALLERGIC REACTION; SHE WAS ADMITTED TO THE HOSPITAL FOR 2 OR 3 DAYS AND THEN DISCHARGED. SHE REPORTED THAT HER ALLERGIC REACTION SYMPTOMS HAVE ALL RECOVERED BUT SHE WAS NOW HAVING SOME PROBLEMS WITH HER STOMACH, "A HARD KNOT UNDERNEATH ABOVE HER BELLY BUTTON A GOOD WAYS". SHE REPORTED UNDERGOING A BARIUM SWALLOW TEST FOR THE STOMACH PROBLEMS AND THAT HER DOCTOR SUSPECTED AN ULCER. SHE REPORTED IT WAS UNCLEAR WHETHER THE SYMPTOMS SHE EXPERIENCED WERE DUE TO HER USING THE FIXODENT CLEANSER FOR THE FIRST TIME OR DUE TO TAKING BACTRIM TO TREAT BRONCHITIS CONCURRENTLY WITH USE OF THE FIXODENT CLEANSER TABLETS. SHE MENTIONED THAT SHE HAD RINSED AND BRUSHED HER DENTURES BEFORE PUTTING THEM IN HER MOUTH. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25809 FIXODENT PLUS SCOPE DENTURE CLEANSER (POTASSIUM MONOPERSULFATE 0.868 G, SODIUM P DENTURE CLEANSER EFT PROCTER & GAMBLE MFG. GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O BIPOLAR MEDICATION