BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2894235 · Received December 27, 2012

    Report

    Report Number
    2951250-2012-00060
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 11, 2012
    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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD ESSURE PROCEDURE ON (B)(6) 2012. PT BEGAN TO EXPERIENCE PAIN ON RIGHT SIDE SHORTLY AFTER THE PROCEDURE. THE THREE MONTH HSG TEST DONE (B)(6) 2012 INDICATING A PATENCY ON THE LEFT SIDE AND A POSSIBLE PERFORATION AT THE CORNUA ON THE RIGHT SIDE. ON (B)(6) 2012, PHYSICIAN DID A HYSTEROSCOPY AND LAPAROSCOPY, FOLLOWED BY A BILATERAL SALPINGECTOMY. LAPAROSCOPY DID NOT FIND A PERFORATION OF THE CORNUA OR ANYTHING ABNORMAL. FLUOROSCOPY IMAGES SHOWED THAT THE TIP OF THE RIGHT DEVICE WAS IN UTERUS. SHE COULD NOT SEE THE LEFT DEVICE HYSTEROSCOPICALLY. DURING THE SALPINGECTOMY, IT FELT AS IF THE LEFT DEVICE WAS IN THE MESOSALPINX JUST OUTSIDE THE FALLOPIAN TUBE. SHE SENT EVERYTHING TO PATHOLOGY. PHYSICIAN ATTRIBUTED PT'S PAIN TO THE ESSURE DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention