BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17201734 · Received June 23, 2023

    Report

    Report Number
    MW5118814
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    January 1, 2013
    Report Date
    June 20, 2023
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SO I HAD THE ESSURE PROCEDURE BACK IN 2008/2009 DIDN'T HAVE A PROBLEM WITH UNTIL THE DATE I MENTION I AM HAVING STOMACH PAIN AND MY PERIODS HAVE BEEN LONGER THAN NORMAL, AND I NEVER HAD OR DID ANY TYPE OF TESTING TO MAKE SURE IT WAS OK. I NEVER HAD ANY TESTS INVOLVED WITH THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265172 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER MEDICAL CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other