BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2850538 · Received November 16, 2012

    Report

    Report Number
    2951250-2012-00048
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    November 1, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ESSURE PROCEDURE WAS DONE (B)(6) 2012. PT HAD SOME PAIN ON LEFT SIDE WHICH HAD SUBSIDED UNTIL RECENTLY WHEN PAIN SYMPTOMS RE-OCCURRED. AN ULTRASOUND DONE IN (B)(6) DID NOT REVEAL ANYTHING. IN (B)(6), THE PT REQUESTED THAT BOTH ESSURE DEVICES BE REMOVED. HER ESSURE PHYSICIAN REMOVED BOTH DEVICES HYSTEROSCOPICALLY AND THEN DID A BILATERAL LAPAROSCOPIC TUBAL LIGATION. DURING SURGERY, PHYSICIAN FOUND THAT THE DEVICE ON LEFT SIDE HAD PERFORATED THE FALLOPIAN TUBE. HE ATTRIBUTED THE ESSURE DEVICE AS THE CAUSE OF HER PAIN. PT PAIN SYMPTOMS HAVE RESOLVED SINCE REMOVAL SURGERY.

    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