BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3623974 · Received February 12, 2014

    Report

    Report Number
    MW5034296
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 1, 2011
    Report Date
    January 17, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILURE. COILS IMPLANTED (B)(6) 2010. 100% BLOCKAGE HSG CONFIRMED (B)(6) 2010. CONFIRMED VIABLE PREGNANCY (B)(6) 2011. BABY BOY BORN (B)(6) 2011, DUE DATE WAS (B)(6) 2011. BABY FINE, MOTHER NOT SO LUCKY. I AM FILING A SEPARATE REPORT CONCERNING THE MOTHERS POST DELIVERY, NEAR FATAL, COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93418 ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR Hospitalization| O