BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3983091 · Received August 6, 2014

    Report

    Report Number
    MW5037596
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    March 21, 2011
    Report Date
    June 25, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    #MEDWATCHER #FOLLOWUP1 #FDAMW5037596 #(B)(4). DURING MY IMPLANTATION, MY UTERUS WAS PUNCTURED BY THE HYSTEROSCOPE, AND MY PROCEDURE WAS TERMINATED WITH ONLY THE LEFT SIDE IMPLANTED AND THEY WERE UNABLE TO TELL IF IT WAS PLACED CORRECTLY AS A RESULT; 500 CC'S OF SALINE SOLUTION LEAKED IN TO MY ABDOMINAL CAVITY AS A RESULT OF THE PERFORATED UTERUS, AS STATED IN MY MEDICAL RECORD. I CHOSE NOT TO RETURN TO HAVE THE RIGHT SIDE PLACED DUE TO THE DIFFICULTY DURING IMPLANTATION OF MY LEFT COIL, I NEVER RECEIVED AN ID CARD WITH MY LOT/KIT NUMBER AFTER IMPLANTATION. I HAVE SINCE HAD A HYSTERECTOMY TO REMOVE THE COIL. ((B)(6), 2014) I THEN EXPERIENCED A VAGINAL CUFF DEHISCENCE DURING INTERCOURSE (B)(6), 2015 AND, AFTER A TRIP TO THE EMERGENCY ROOM, HAD EMERGENCY SURGERY TO FIX THE DEHISCENCE. (I HAD BEEN CLEARED TO RESUME ALL ACTIVITIES BY THE DOCTOR WHO PERFORMED THE HYSTERECTOMY AS OF (B)(6), 2015.)

    Description of Event or Problem · 1

    (B)(4). I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE ON (B)(6) 2011. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. THIS DEVICE HAS A THREE YEAR SHELF LIFE, HOWEVER, I DO NOT HAVE THAT EXPIRATION DATE. THE ONSET OF MY COMPLAINT STARTED ON (B)(6) 2011. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE. PELVIC PAIN, HOT FLASHES, NIGHT SWEATS, LOSS OF SEX DRIVE, BLEEDING AFTER SEX, PAINFUL INTERCOURSE, FREQUENT URINATION, BREAST TENDERNESS, ALL OVER BODY ACHES, BOWEL ISSUES, SEVERE BLOATING, MIGRAINES, DIMINISHED BRAIN FUNCTION, NUMBNESS/TINGLING IN FINGERS, SHAKINESS, RASHES, INSOMNIA, EXCESSIVE SWEATING. I HAVE BEEN SEEN BY 4 DOCTORS. I HAVE BEEN DIAGNOSED WITH THE FOLLOWING CONDITIONS: INTERNAL AND EXTERNAL HEMORRHOIDS, CHRONIC INFLAMMATION. THE DEVICE IS STILL INSIDE OF ME. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461041 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 37.000 YR Other| S