BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3193606 · Received June 21, 2013

    Report

    Report Number
    MW5030683
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 8, 2007
    Report Date
    June 21, 2013
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE COILS INSERTED, NEGATIVE SIDE EFFECTS FOLLOWING. ADENOMYOSIS, ENDOMETRIOSIS, INTERSTITIAL CYSTITIS, MIGRAINES, LOWER LUMBAR DISC DAMAGE/INJURY. SEVERE FOOD AND ENVIRONMENTAL ALLERGIES. NICKEL ALLERGY. CHRONIC FATIGUE. POSSIBLE PREGNANCIES/MISCARRIAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282542 ESSURE ESSURE HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O