BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFRIGERATED TEST YOLK MEDIUM

    MDR report key: 23435926 · Received October 31, 2025

    Report

    Report Number
    MW5178317
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Report Date
    October 26, 2025
    Manufacturer
    IRVINE SCIENTIFIC, LLC.
    Product Code
    MQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    21 CFR 1271 ¿ HCT/PS REFRIGERATION TEST YOLK MEDIUM IS BEING USED FOR FREEZING SEMEN BY ADDING GLYCEROL WITHOUT A VALIDATION FOR OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084698 REFRIGERATED TEST YOLK MEDIUM MEDIA, REPRODUCTIVE MQL IRVINE SCIENTIFIC, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown