BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2121757 · Received May 20, 2011

    Report

    Report Number
    2951250-2011-00030
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 8, 2011
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING. THE CODE (B)(4) WAS REPLACED WITH (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, SALES REP CALLED IN AN ISSUE REPORTED BY A PHYSICIAN WHERE A PT PRESENTED WITH PAIN AND AT HER (THE PT'S) REQUEST, DR (B)(6) REMOVED THE DEVICES LAPAROSCOPICALLY. FOLLOW UP TO GATHER ADDITIONAL INFORMATION FROM PHYSICIAN / PHYSICIAN'S OFFICE WAS PERFORMED ON (B)(6) 2011. CONFIRMATION OF MEDICAL NECESSITY AND RESOLUTION OF PT SYMPTOMS WAS NEVER PROVIDED. THE SALES REP DID STATE IN A FOLLOW UP CALL THAT THE DR DID NOT MENTION MEDICAL NECESSITY. THE PT FELT PAIN, A TEST WAS DONE TO RULE OUT INFECTION, AND PT WANTED REMOVAL. NO OTHER TREATMENT WAS ATTEMPTED BEFORE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 782774

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention