BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1545832 · Received November 23, 2009

    Report

    Report Number
    MW5013679
    Event Type
    Other
    Date Received
    November 23, 2009
    Date of Event
    November 20, 2009
    Report Date
    November 20, 2009
    Product Code
    HHS
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ESSURE COILS WOULD NOT DEPLOY. QTY 2 WERE DEFECTIVE/WASTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE ESSURE HHS 664443

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other