BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRENA

    MDR report key: 16775587 · Received April 20, 2023

    Report

    Report Number
    16775587
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 14, 2023
    Manufacturer
    BAYER HEALTHCARE PHARMACEUTICALS
    Product Code
    HHF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING OPERATIVE HYSTEROSCOPY WITH IUD REMOVAL AND PLACEMENT OF MIRENA IUD, THE MIRENA DEVICE (GTIN 00350419423014, LOT TU03FU7, EXP. (B)(6)2025) FAILED TO DEPLOY/INSERT. A NEW MIRENA DEVICE WAS OBTAINED AND FUNCTIONED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157464 MIRENA IUD HHF BAYER HEALTHCARE PHARMACEUTICALS TU03FU7

    Patients

    Seq Age Sex Outcome Treatment
    1 6935 DA Female