BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-ICE

    MDR report key: 20994298 · Received December 20, 2024

    Report

    Report Number
    2416455-2024-00006
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    August 22, 2023
    Report Date
    January 17, 2025
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    *AT THE TIME OF THE INITIAL REPORT, THIS WAS CLASSIFIED AS "INFORMATION". THIS TICKET WAS LATER IDENTIFIED AS AN ADVERSE EVENT ON 11/20/2024.

    Description of Event or Problem · 0

    ON 6/17 COLTENE RECEIVED A REPORT FROM A USER OF ENDO-ICE. THE REPORTER STATED THAT ON AUGUST 22, 2023, WHILE ASSISTING A DOCTOR IN A PROFESSIONAL SETTING, SHE WAS INADVERTENTLY EXPOSED TO ENDO-ICE. ACCORDING TO HER STATEMENT, THE CHEMICAL WAS SPRAYED IN HER DIRECTION, AND HER PPE DID NOT ADEQUATELY PROTECT HER. THE REPORTER CLAIMED THAT THE CHEMICAL MADE DIRECT CONTACT WITH HER FACE AND EYES, RESULTING IN THE FOLLOWING INJURIES: · CHEMICAL BURNS. · CORNEAL ABRASIONS. · HYPERESTHESIA. · PHOTOPHOBIA. SHE FURTHER STATED THAT SHE SUBSEQUENTLY DEVELOPED CORNEAL NEURALGIA, WITH HEIGHTENED SENSITIVITY TO LIGHT, AIR, AND TEMPERATURE CHANGES. THE REPORTER ASSERTED THAT THESE INJURIES HAVE SIGNIFICANTLY IMPACTED HER INDEPENDENCE AND QUALITY OF LIFE AND INQUIRED ABOUT REPORTS ON SHORT-TERM AND LONG-TERM DAMAGE ENDO-ICE CAUSES TO THE SKIN AND EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617482 ENDO-ICE PULP TESTER EAT COLTENE WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other