BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEGLOBAL MEDIA

    MDR report key: 22469280 · Received July 10, 2025

    Report

    Report Number
    1216677-2025-00037
    Event Type
    Injury
    Date Received
    July 10, 2025
    Report Date
    August 28, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQL
    PMA / PMN Number
    K142991
    Removal / Correction Number
    Z-1089-2024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: 2024 D4: LGGG-020 LOT 231020-018741, LGGG-050 LOT 231020-018742, OR LGGG-100 LOT 231020-018743 DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LEGAL DEPARTMENT THAT THE PATIENT WAS BORN WITH LISSENCEPHALY. THE PATIENT WAS ALLEGEDLY CONCEIVED USING AN UNKNOWN LGGG PRODUCT BELIEVED TO HAVE BEEN ASSOCIATED WITH THE RECALL IN 2023. NO ADDITIONAL INFORMATION CURRENTLY AVAILABLE. UNK LGGG 2025-06-0000515.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602060 LIFEGLOBAL MEDIA IVF MEDIUM MQL COOPERSURGICAL, INC. SEE H11 SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female Congenital Anomaly| O