BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3792978 · Received May 6, 2014

    Report

    Report Number
    MW5035896
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    January 1, 2008
    Report Date
    March 15, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HODGKIN'S LYMPHOMA, CHRONIC PELVIC PAIN, SEVERE ALLERGY TO NICKEL AND SEVERAL CHEMICAL PRESERVATIVES DEVELOPED. PRIOR TO HAVING A SALPINGECTOMY AND HYSTERECTOMY I HAD PAINFUL HEAVY PERIODS. I ALSO EXPERIENCED ANEMIA FROM HEAVY BLEEDING AND IT REQUIRED IRON INFUSIONS. (B)(4).

    Description of Event or Problem · 1

    (B)(4). DOCTOR ALSO REPORTED CASE 2951250-2014-00041.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272766 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36.000 YR Hospitalization| L| O| S