BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3736747 · Received April 9, 2014

    Report

    Report Number
    MW5035550
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    August 10, 2012
    Report Date
    March 28, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE ON (B)(6) 2012. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMERLY BY CONCEPTUS INC. MY LOT NUMBER IS 893038 MY MODEL NUMBER IS ESS305. 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) 2012. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE. WEIGHT LOSS; PELVIC AND VAGINAL PAIN; IRREGULAR AND ABNORMAL MENSES; ABDOMINAL PAIN; FLANK PAIN; PAIN IN LIMBS; CHEST PAIN; HEART PALPITATIONS; DIZZINESS; NUMBNESS AND/OR TINGLING IN LIMBS AND FACE; RASH; METALLIC TASTE IN MOUTH; DIFFICULTY WITH MEMORY; SWELLING AND INFLAMMATION OF VEINS; (B)(6); WEAKNESS; SHORTNESS OF BREATH; IRRITATED AND DRY EYES; SORES IN EYES, NOSE, MOUTH; FEVER THAT COMES AND GOES; CHILLS; PAIN IN LYMPH NODES; MUSCLE ACHE; JOINT PAIN; BONE PAIN; PAINFUL INTERCOURSE; DIGESTIVE PROBLEMS. I HAVE BEEN SEEN BY 6 DOCTORS. I HAVE HAD THE FOLLOWING SURGERIES DUE TO ESSURE: SALPINGECTOMY. THE DEVICE HAS BEEN REMOVED (B)(6) 2012. I DO NOT KNOW IF THE DEVICE WAS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214478 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36.000 YR Disability ESSURE