BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9506088 · Received December 20, 2019

    Report

    Report Number
    9506088
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 20, 2019
    Manufacturer
    UNKNOWN
    Product Code
    HHF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR HYSTEROSCOPY FOR INTRAUTERINE DEVICE (IUD) REMOVAL AFTER FAILED REMOVAL ATTEMPT IN MD OFFICE. THE REMOVAL WAS COMPLICATED DUE TO A PORTION OF THE IUD THAT WAS EMBEDDED IN THE UTERUS. DURING REMOVAL, THE IUD BROKE LEADING TO A SMALL PIECE BEING RETAINED IN THE UTERUS. BRAND AND MODEL OF IUD IS UNKNOWN TO THIS WRITER. A DESCRIPTION OF IUD WAS PROVIDED: WHITE PLASTIC T-SHAPED INTRAUTERINE DEVICE, WHICH IS 3.3 CM X 3.2 CM WRAPPED IN ORANGE BROWN COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294842 UNKNOWN DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER HHF UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Other