BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2041203 · Received March 29, 2011

    Report

    Report Number
    2951250-2011-00016
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: CONFERRED WITH CONSULTING PHYSICIANS WHO SPOKE W/ REPORTING DOCTOR. THEY DISCUSSED THE POSSIBILITY OF SEEDING THE INFECTION INTO THE PELVIS AFTER DRAINING THE ABSCESS, AS OPPOSED TO PERFORMING A HYSTERECTOMY RIGHT THEN AND THERE. THE TWO DOCTORS BOTH THOUGHT IT WAS HIGHLY UNUSUAL (AND UNLIKELY) TO HAVE A PID FROM THE ESSURE PROCEDURE 2 YEARS LATER. CONCEPTUS HAS MADE THE CONSERVATIVE DECISION TO REPORT THIS EVENT ON THIS MDR, EVEN THOUGH NO DIRECT LINK BETWEEN THE DEVICES AND THE INFECTION HAVE BEEN MADE.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, DOCTOR REPORTED A PATIENT WHO HAD ESSURE PLACED IN (B)(6) 2009 BY ANOTHER DOCTOR. PATIENT REPORTED HAVING THE 3 MONTH POST PROCEDURE HSG WHICH DOCUMENTED TUBAL OCCLUSION. A FEW DAYS AGO, SHE PRESENTED TO THE EMERGENCY ROOM AT (B)(6) WITH FEVER, SEVERE PAIN, ELEVATED WBC CONSISTENT WITH SOME INFECTION PROCESS. LAPAROSCOPY PERFORMED, CORNUAL ABSCESSES DRAINED, IV-ANTIBIOTICS ADMINISTERED. ADDITIONAL FOLLOW-UP: PATIENT TAKEN BACK INTO OPERATING ROOM AFTER ABOUT 36 HOURS AND A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WAS PERFORMED. PHYSICIAN STATED HE DID NOT FEEL THE INFECTION WAS CAUSED BY THE ESSURE DEVICES, BUT THE POSSIBILITY THAT THEY CONTRIBUTED TO THE LACK OF RESPONSE TO ANTIBIOTICS. THE MORNING FOLLOWING THE HYSTERECTOMY, THE PATIENT'S CONDITION IMPROVED DRAMATICALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention