BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4902043 · Received July 9, 2015

    Report

    Report Number
    MW5043788
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    April 2, 2009
    Report Date
    November 6, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). DESDE QUE ME PUSIERON ESSURE TENGO SANGRADO QUE ME DURAN 2 MESE IENDO A EMERGENCIA ME DAN DOLORES FUERTE MI ESTANDOACUTE;MAGO SE INFLA TENGO CALAMBRE EN EL ESTANDOACUTE;MAGO NANDAACUTE;USEA OCASIANDOACUTE;N EN MI PARTE ANDIACUTE;NTIMA SANGRADO FUERTE QUE SE ME CAE AL PISO (B)(6) GRANDE ARDOR A ORINAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448477 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 27.000 YR Hospitalization| O