BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERGRIP DENTURE ADHESIVE CREAM

    MDR report key: 354833 · Received August 23, 2001

    Report

    Report Number
    2210721-2001-00001
    Event Type
    Injury
    Date Received
    August 23, 2001
    Date of Event
    August 14, 2001
    Report Date
    August 22, 2001
    Manufacturer
    WARNER LAMBERT CO.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER, WHO WAS HOSPITALIZED FOR CHEST PAIN IN 2001, REPORTED THAT DURING THE HOSPITALIZATION, CONSUMER USED 1 EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER TABLET (POTASSIUM MONOPERSULFATE, NA PERBORATE MONOHYDRATE) FOR THE FIRST TIME TO CLEAN CONSUMER'S DENTURES. THE FOLLOWING MORNING, CONSUMER RINSED AND BRUSHED CONSUMER'S DENTURES AND APPLIED EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYL CELLULOSE NA, GANTREZ) AS A DENTURE ADHESIVE, WHICH CONSUMER HAD USED FOR YEARS WITHOUT INCIDENT. IMMEDIATELY AFTER INSERTING THE DENTURES IN CONSUMER'S MOUTH, CONSUMER'S THROAT AND GUMS BEGAN TO SWELL. CONSUMER'S THROAT BECAME ITCHY AND HIVES OCCURRED. A PHYSICIAN WAS CALLED AND IN THE INTERIM, THE CONSUMER USED CONSUMER'S EPI-PEN (EPINEPHRINE AUTO-INJECTOR). THE ANAPHYLACTIC REACTION WAS TREATED WITH ORAL BENADRYL (DOSE UNSPECIFIED) AND THE PT WAS INTUBATED. CONSUMER'S VOICE BECAME "HOARSE" AS A RESULT OF THE INTUBATION. THE USE OF EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER WAS DISCONTINUED. THE EVENT RESOLVED WITHIN A FEW MINUTES. IT IS UNKNOWN IF THE USE OF EFFERGRIP DENTURE ADHESIVE CREAM WAS DISCONTINUED. AS OF 6 DAYS FOLLOWING THE EVENT, THE CONSUMER WAS DISCHARGED FROM THE HOSP. ATTEMPTS ARE BEING MADE TO FOLLOW-UP WITH THE TREATING PHYSICIAN FOR MORE INFO ON THE INCIDENT. THE CONSUMER'S CARDIOLOGIST REPORTED THAT HE HAD NOT BEEN AWARE OF THIS INCIDENT. HE STATED THAT IT IS UNLIKELY THAT THE PT'S ANAPHYLACTIC REACTION WAS CAUSED BY THE USE OF AN ORAL TOPICAL AGENT LIKE EFFERDENT AND EFFERGRIP. HE STATED THAT IT IS MORE LIKELY THAT THIS REACTION WOULD OCCUR IN RELATION TO A SYSTEMIC AGENT. BASED ON THE CONSUMER'S PAST USE OF EFFERGRIP DENTURE ADHESIVE CREAM FROM THE SAME TUBE INVOLVED IN THIS INCIDENT WITHOUT ANY ADVERST EVENT, IT IS UNLIKELY THAT EFFERGRIP CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38941 EFFERGRIP DENTURE ADHESIVE CREAM DENTURE PRODUCT EFT WARNER LAMBERT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention