BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMDOGAIN, COURSE

    MDR report key: 23252222 · Received October 9, 2025

    Report

    Report Number
    0001222315-2025-002824
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 7, 2025
    Manufacturer
    INSTITUT STRAUMANN AG
    Product Code
    NQA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STRAUMANN WAS INFORMED VIA A CUSTOMER COMPLAINT (ID (B)(4)) ON SEPTEMBER 10TH, 2025 THAT A DOCTOR USED 440.230V10 EMDOGAIN COURSE MATERIAL BATCH EPZM8 IN A PATIENT ON (B)(6) 2025. DOCTOR CONFIRMED ON SEPTEMBER 16TH THAT THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS PRODUCT ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584605 EMDOGAIN, COURSE EMDOGAIN, COURSE NQA INSTITUT STRAUMANN AG EPZM8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention