BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 1913147 · Received November 19, 2010

    Report

    Report Number
    1913147
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DOCTOR STATED THAT THE DEVICE WOULD NOT RELEASE THE COIL AS IT WAS SUPPOSED TO DO. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW ONE WAS USED WITH NO FURTHER INCIDENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================MALFUNCTION- WOULD NOT RELEASE COIL====================== MANUFACTURER RESPONSE FOR CONTRACEPTIVE DEVICE, ESSURE======================WILL SEND PACKAGING TO RETURN IT TO COMPANY FOR EVALUATION. WILL SEND NEW PRODUCT FREE OF CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 ESSURE CONTRACEPTIVE DEVICE HHS CONCEPTUS, INC. * 632025

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO OTHER THERAPIES