BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    EDGEEVOLVE

    MDR report key: 18862022 · Received March 7, 2024

    Report

    Report Number
    3008857765-2024-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    October 10, 2023
    Report Date
    March 7, 2024
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR DELAY IN REPORTING DUE TO MISPLACEMENT OF EMAIL COMMUNICATIONS TO THE MANUFACTURER (US ENDODONTICS). THE PATIENT WAS REFERRED TO A SPECIALIST. NO FOLLOW-UP APPOINTMENT SCHEDULED. DISTRIBUTOR IS STILL TRYING TO REACH OUT TO CLINICIAN AND SPECIALIST TO FIND OUT OUTCOME OF REFERRALS.

    Description of Event or Problem · 0

    (B)(6) CONTACT PERSON CALLED TO LET US KNOW THAT THEY HAD TWO FILES SEPARATE AT 3MM AND NEITHER WERE ABLE TO BE REMOVED. THEY HAVE REQUESTED A REFUND. THE PATIENT WAS REFERRED TO A SPECIALIST. NO FOLLOW-UP APPOINTMENT SCHEDULED. DISTRIBUTOR IS STILL TRYING TO REACH OUT TO CLINICIAN AND SPECIALIST TO FIND OUT OUTCOME OF REFERRALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379120 EDGEEVOLVE ENDODONTIC FILE EKS US ENDODONTICS, LLC. EE250825 121322276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose