BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4781015 · Received May 19, 2015

    Report

    Report Number
    MW5042757
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    May 2, 2014
    Report Date
    May 4, 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). AFTER INSERTED, I BLEED FOR A MONTH AND HALF, HAD LOWER BACK PAIN AND SEVERE PAIN ON MY LEFT SIDE . THEN GAIN ABOUT 40 LBS AND STILL HAD PAIN EVERYDAY IN LOWER ABDOMEN, DON'T HAVE REGULAR PERIODS, I HAVEN'T BLEED FOR MORE THAN ONE DAY A MONTH SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325182 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36.000 YR Hospitalization| O DEPO AT THE SAME TIME THEY WERE IMPLANTED