BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5104663 · Received September 25, 2015

    Report

    Report Number
    MW5056477
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    December 22, 2011
    Report Date
    September 24, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). TERRIBLE PERIODS, PAIN, BLOATING. THEN HAD ABLATION FOR THE BAD PERIODS. SUCCESSFUL HGC TEST (B)(6) 2012. PAIN CONTINUE VERY BAD. HAD HYSTERECTOMY (B)(6) 2012 ALMOST 1 YEAR AFTER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637055 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 43.000 YR Hospitalization