BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOSURE HOLOGIC

    MDR report key: 18781510 · Received February 23, 2024

    Report

    Report Number
    MW5151962
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 12, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRODUCT PROBLEM (DEFECTS/MALFUNCTIONS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102520 MYOSURE HOLOGIC HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other