BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3835933 · Received May 28, 2014

    Report

    Report Number
    MW5036306
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    December 13, 2013
    Report Date
    May 21, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGINNING IN (B)(6) WERE THE SEVERE UTERINE CRAMPS (SO SEVERE I WOULD DOUBLE OVER). THE LAST WEEK OF (B)(6), MY EYES BEGAN TO HAVE A SKIN REACTION. I ENDED UP GOING TO URGENT CARE IN (B)(6), FOLLOWING THE HSG TEST WITH EYE IRRITATION AND SKIN ITCHING. I HAVE SINCE BEEN TO MY FAMILY DOCTOR AND AN ALLERGIST. I WAS NOT PREVIOUSLY ALLERGIC TO THE MATERIALS I CURRENTLY AM AND STILL HAVE THE PAIN, CHRONIC FATIGUE AND HAVE BEGUN ALLERGY SHOTS. PATCH TESTING SHOWS ALLERGIES TO SEVERAL MATERIALS IN THE COILS. (B)(4). UPDATE ON (B)(6) 201421: LOT # 30-257-DK, EXPIRATION JUNE 1, 2015. HAVE SINCE BEEN TO MY OB/GYN AND WILL BE HAVING A HYSTERECTOMY AND FALLOPIAN TUBES REMOVED (B)(6). I CONTINUE TO HAVE DEBILITATING CRAMPS, ALLERGY ISSUES AND CHRONIC FATIGUE. ALSO WANTING TO NOTE THAT BOTH PLACEMENT AND HSG TESTING WERE DONE WHILE UNDER NO ANESTHESIA RESULTING IN EXTREME DISCOMFORT AND PAIN DURING BOTH PROCEDURES.

    Description of Event or Problem · 1

    (B)(4). LOT # 30-257-DK, EXPIRATION JUNE 1, 2015. HAVE SINCE BEEN TO MY OB/GYN AND WILL BE HAVING A HYSTERECTOMY AND FALLOPIAN TUBES REMOVED (B)(6). I CONTINUE TO HAVE DEBILITATING CRAMPS, ALLERGY ISSUES AND CHRONIC FATIGUE. ALSO WANTING TO NOTE THAT BOTH PLACEMENT AND HSG TESTING WERE DONE WHILE UNDER NO ANESTHESIA RESULTING IN EXTREME DISCOMFORT AND PAIN DURING BOTH PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313299 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 35.000 YR Other