BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC WAX

    MDR report key: 18430085 · Received January 2, 2024

    Report

    Report Number
    2416455-2023-00001
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    October 27, 2023
    Report Date
    March 11, 2024
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EGD
    UDI-DI
    0+D661H0082019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE WAX WAS RETURNED FOR INVESTIGATION. THIS WAX IS NOT MADE WITH BEESWAX AND THERE ARE NO CURRENT PRODUCTS MADE AT COLTENE WITH BEESWAX. IT WAS SENT TO THE RAW MATERIAL SUPPLIER FOR TESTING. THIS WAX IS A MICROCRYSTALLINE WAX BLEND, WHICH IS A CLASS OF CHEMICALS THAT INCLUDE PARAFFIN WAXES AND HYDROCARBON WAXES. TESTING ON THE PRODUCT CONFIRMED THAT IT CONTAINS NO BEESWAX AND THERE WAS NO BEESWAX CONTAMINATION. NO ISSUE WAS IDENTIFIED WITH THE WAX RETURNED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    ONE OF THEIR HYGIENISTS HAD AN ALLERGIC REACTION TO THE WAX. SHE IS HIGHLY ALLERGIC TO BEESWAX. EPI PEN WAS ADMINISTERED AND SHE WAS SENT TO AN URGENT CARE OFFICE, SHE WAS HOSPITALIZED AND INTUBATED LATER THAT DAY FOR 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559617 HYGENIC WAX WHITE WAX ROPES SQUARE EGD COLTENE WHALEDENT INC. K80917 0+D661H0082019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R