BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4903498 · Received July 9, 2015

    Report

    Report Number
    MW5043852
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    December 17, 2009
    Report Date
    July 15, 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). INCREASED CRAMPING AND HEAVIER PERIODS, PROGRESSING OVER TIME TO BECOMING BEDRIDDEN UNABLE TO STAND UPRIGHT DUE TO DEBILITATING PAIN, INCREASED BLOOD PRESSURE, DEVELOPED METABOLIC SYNDROME, WEIGHT GAIN, HAIR LOSS, BRITTLE TEETH, JOINT PAIN, SLEEP APNEA, CHRONIC FATIGUE

    Description of Event or Problem · 1

    (B)(4). HAD A SUPRACERVICAL HYSTERECTOMY/BILATERAL SALPINGECTOMY TO REMOVE ESSURE ON (B)(6) 2015. LOST (B)(6) LBS IN THE FIRST 2 WEEKS POST OP, JOINT PAIN, CHRONIC FATIGUE, HAIR LOSS, PAIN, BLOOD PRESSURE ISSUES, AND NEARLY ALL METABOLIC ISSUES HAVE SINCE RESOLVED IN THE 6 WEEKS POST OP. PATHOLOGY REPORT LISTED 2 CYSTS ON TUBES, ONE ESSURE COIL WAS BENT INTO A 90 DEGREE ANGLE, ONE STRETCHED OUT SEVERAL INCHES IN LENGTH. UTERUS WAS ENLARGED, EXCESSIVE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445177 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40.000 YR Hospitalization| O| R