BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIL FOR EMBRYO CULTURE

    MDR report key: 16120606 · Received January 9, 2023

    Report

    Report Number
    16120606
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 6, 2022
    Report Date
    December 21, 2022
    Manufacturer
    FUJIFILM IRVINE SCIENTIFIC, INC.
    Product Code
    MQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EMBRYOLOGIST NOTICED DEGENERATION OF EMBRYOS TREATED WITH MINERAL OIL USED TO PREVENT EVAPORATION. THE EMBRYOLOGIST THEN PERFORMED A QA/QI TEST OF THE MINERAL OIL ON MOUSE EMBRYOS AND NOTED SAME EFFECT. APPROXIMATELY 20 PATIENTS MAY BE AFFECTED. THE OIL HAS BEEN REMOVED FROM USE. MANUFACTURER RESPONSE FOR MINERAL OIL, OIL FOR EMBRYO CULTURE (PER SITE REPORTER) NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394814 OIL FOR EMBRYO CULTURE MEDIA, REPRODUCTIVE MQL FUJIFILM IRVINE SCIENTIFIC, INC. 9305-100ML 0000011351

    Patients

    Seq Age Sex Outcome Treatment
    1 Female