BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3854866 · Received May 21, 2014

    Report

    Report Number
    2951250-2014-00161
    Event Type
    Injury
    Date Received
    May 21, 2014
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN THE UNITED STATES ON (B)(6)2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED AND EXPERIENCED DIFFICULTY BREATHING. NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT IS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATIONS. ON (B)(6) 2014, THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AT UNK IMPLANTED FOR CONTRACEPTION. IN (B)(6) 2014 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF DIFFICULTY BREATHING. AT THE TIME OF THIS REPORT SHE WAS STILL IN THE HOSPITAL. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN DIFFICULTY BREATHING AND ESSURE IS NOT REPORTED. FOLLOW-UP ON (B)(6) 2014, PHYSICIAN RESPONDED TO FOLLOW-UP CALL. THEY STATED PATIENT'S INITIALS WERE WRONG, CORRECT INITIALS ARE (B)(6). REPORTER STATED AS FAR AS HE REMEMBERS PATIENT HAS TO CONCURRENT CONDITIONS NOR RECEIVED ANY CONCURRENT MEDICATION. ON (B)(6) 2014, PATIENT HAD ESSURE INSERTED. SHE HAD SOME THROAT SWELLING. PATIENT WENT TO THE ER (EMERGENCY ROOM) IN A HOSPITAL WHERE REPORTING PHYSICIAN IS NOT A STAFF MEMBER. PATIENT GOT ADMITTED IN THE HOSPITAL FOR A POSSIBLE ALLERGIC REACTION TO ESSURE. SHE HAD SOME DIFFICULTY BREATHING, SHORTNESS OF BREATH, POOR DENTITION. SHE WAS TREATED WITH EPINEPHRINE INJECTIONS, STEROIDS FOR SWELLING OF FACE. SHE HAD OTHER SCANS DONE AND IN HOSPITAL SHOWED NO ISSUE AND CAME BACK NEGATIVE FOR ABSCESS. REPORTER DOES NOT HAVE THOSE RESULTS. PATIENT WENT BACK TO REPORTER FOR FOLLOW-UP AND WAS STILL HAVING VAGINAL BLEEDING AND FOUND TO BE HAVING A FIBROID. SHE MAY OR MAY NOT BE HAVING A NICKEL WITH BILATERAL SALPINGECTOMY ALONG WITH ESSURE REMOVAL ON (B)(6) 2014. SHE CAME FOR POSTOPERATIVE FOLLOW-UP ON (B)(6) 2014 AND HAS HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303999 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization