BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4939470 · Received July 24, 2015

    Report

    Report Number
    MW5044730
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    May 1, 2009
    Report Date
    June 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). THE PROCEDURE TOOK MUCH LONGER THA PLANNED. I WAS NEVER TOLD I WOULD NEED A RIDE HOME. I WANT ABLE TO TAKE ANY PAIN RELIEF MEDICATION DURING THE PROCEDURE. I WATCHED AS THE DOCTOR INSERTED BOTH COILS. ON MY LEFT SIDE, THE DOCTOR SAID "OPPS". THE COIL WENT TOO FAR IN, NO TRAILING COILS WERE VISIBLE. I HAVE HAD HORRIBLE PAIN ON THAT SIDE SO SEVERE I COULDN'T MOVE. WEIGHT GAIN, ENDOMETRIOSIS, JOINT PAIN. I HAVE WANT THEM REMOVED BUT CANNOT AFFORD IT. I'VE HAD SURGERY FOR THE ENDOMETRIOSIS AND HAD THE COIL PLACEMENT CHECKED. THE LEFT SIDE COIL HIS MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481939 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 47.000 YR Hospitalization