BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4902253 · Received July 9, 2015

    Report

    Report Number
    MW5043801
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    April 17, 2015
    Report Date
    June 6, 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). I HAD UNBEARABLE PAIN, LIKE MISCARRIAGE CRAMPS, DIZZINESS, NAUSEA AND IT HAD LASTED FOR A WEEK SO I WENT TO ER AND THIS LIKE MANY TIMES BEFORE THE DOCTOR DIAGNOSED IT AS ABNORMAL UTERINE BLEEDING. I STILL HAVE THESE PAINS BUT CAN'T AFFORD ANY MORE MEDICAL BILLS TO BUILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446834 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 29.000 YR Hospitalization