BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EFFERDENT ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 348806 · Received August 23, 2001

    Report

    Report Number
    2623619-2001-00005
    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 HOSPTIALIZED FOR CHEST PAIN ON 8/2001, REPORTED THAT DURING THE HOSPITALIZATION, PT USED 1 EFFERDENT ANTI-BACTERIAL DENTURE CLEANSER TABLET (POTASSIUM MONOPERSULFATE, NO PERBORATE MONOHYDRATE) FOR THE FIRST TIME ON THE EVENING TO CLEAN THEIR DENTURES. THE FOLLOWING MORNING PT RINSED AND BRUSHED THEIR DENTURES AND APPLIED EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHLY, CELLULOSE NA, GANTREZ) AS A DENTURE ADHESIVE WHICH PT HAD USED FOR YEARS WITHOUT INCIDENT. IMMEDIATELY AFTER INSERTING THE DENTURES IN THEIR MOUTH, PT'S THROAT AND GUMS BEGAN TO SWELL THEIR MOUTH, PT'S THROAT ITCHY AND HIVES OCCURRED. A PHYSICIAN WAS CALLED AND IN THE INTERIM, THE CONSUMER USED THEIR EPI-PEN (EPINEPHRINE AUTO-INJECTOR). THE ANAPHYLACTIC REACTION WAS TREATED WITH ORAL BENADRYL (DOSE UNSPECIFIED) AND THE PT WAS INTUBATED. THEIR 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 OF THE USE OF EFFERGRIP DENTURE ADHESIVE CREAM WAS DISCONTINUED. AS OF 7 DAYS LATER, 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 SATED THAT IT IS MORE LIKELY THAT THIS REACTION WOULD OCCUR IN RELATION TO A SYSTEMIC AGENT. HOWEVER, IT CANNOT BE RULED OUT THAT THE USE OF EFFERDENT OR EFFERGRIP MAY HAVE POSSIBLY CAUSED THE EVENT. FOLLOW-UP REPORT: QUALITY ASSURANCE STATED THAT THE COMPLAINT SAMPLE WAS NOT RECEIVED. HOWEVER, THE RESERVE SAMPLE WAS EVALUATED. THE RESERVE SAMPLE WAS EXAMINED AND FOUND TO BE SATISFACTORY. TESTING OF THE RESERVE SAMPLE, FOUND IT MET SPECIFICATIONS FOR DESCRIPTION, DISINTEGRATION TIME, PH, FADE TEST AND AVAILABLE OXYGEN. A REVIEW OF THE MFG RECORDS SHOWED THAT ALL RAW MATERIALS WERE ADDED IN THE SPECIFIED QUANTITITES IN ACCORDANCE WITH THE FORMULA. BLENDING TIME, ENVIRONMENTAL CONDITIONS AND EQUIPMENT PARAMETERS WERE USED OR APPLIED IN ACCORDANCE WITH THE APPROVED MFG PROCEDURES. THE TABLETS MET THE SPECIFIED COMPRESSION PARAMETERS. THE INITIAL RELEASE TESTING RESULTS MET SPECIFICATIONS.

    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 THEIR 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 THEIR 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 THEIR EPI-PEN (EPINEPHRINE AUTO-INJECTOR). THE ANAPHYLACTIC REACTION WAS TREATED WITH ORAL BENADRYL (DOSE UNSPECIFIED), AND THE PT WAS INTUBATED. THEIR 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 MINS. 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. HOWEVER, IT CANNOT BE RULED OUT THAT THE USE OF EFFERDENT OR EFFERGRIP MAY HAVE POSSIBLY CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38517 EFFERDENT ANTIBACTERIAL DENTURE CLEANSER DENTURE PRODUCT EFT WARNER-LAMBERT CO. UNK A02031V

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention