BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSIL

    MDR report key: 313027 · Received January 12, 2001

    Report

    Report Number
    MW4002930
    Event Type
    Injury
    Date Received
    January 12, 2001
    Date of Event
    August 20, 2000
    Report Date
    November 3, 2000
    Manufacturer
    REGENT LABS, INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT WAS GIVEN A SAMPLE OF DENTURE CLEANER FROM DENTIST. AFTER USING THE DENTURE CLEANER IN ACCORDANCE WITH THE LABEL DIRECTIONS, THEY HAD AN ALLERGIC REACTION. COMPLAINANT EXHIBITS AN ALLERGIC REACTION BY HAVING A SEIZURE AND LOWERING OF BLOOD PRESSURE. COMPLAINANT HAS KNOWN ALLERGIES TO MSG AND SULFUR. THE LABEL DID NOT LIST THE INGREDIENTS. CONTACTED THE CO, AND THEY REFUSED TO DISCLOSE THE INGREDIENTS OF THE PRODUCT. THE PRODUCT IS CONSIDERED TO BE A MEDICAL DEVICE. THERE IS NO REQUIREMENT FOR THE PRODUCT LABEL TO BEAR AN INGREDIENT STATEMENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/10/01: MFR HAS BEEN SUPPLYING CU-SIL CLEANSER AS A SUPPLIED ADJUNCT TO CU-SIL PARTIAL/DENTURE WEARERS SINCE 1979 AS AN ANTI-FUNGAL/PREVENTATIVE. THIS IS THE FIRST COMPLAINT MFR HAS RECEIVED REGARDING AN ALLERGIC REACTION SINCE THAT TIME. TO MFR'S KNOWLEDGE, THEY HAVE NEVER, EVER RECEIVED A REQUEST FOR AN M.S.D.S. SHEET OR THE FORMULATION, AND IF MFR HAD (EVEN THOUGH THE FORMULATION IS NOT CONSIDERED CO CONFIDENTIAL) MFR WOULD HAVE SUPPLIED THE ATTACHED M.S.D.S. LETTER. MFR'S PRODUCT IS FORMULATED AND PACKAGED IN AN FDA FACILITY. CO SUPPLIES PT CARE & CLEANING INSTRUCTIONS WITH EACH BOTTLE FOR DISTRIBUTION TO USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637 CUSIL DENTURE CLEANER, 4 FLUID OZ BOTTLE EFT REGENT LABS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO