BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 2851108 · Received November 16, 2012

    Report

    Report Number
    2951250-2012-00049
    Event Type
    Other
    Date Received
    November 16, 2012
    Date of Event
    October 18, 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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED TO MANUFACTURER THAT FOLLOWING HSG TEST, (B)(6) PHYSICIAN TOLD HER THAT SHE WAS NOW STERILE AND COULD RELY ON DEVICES. SHE SUBSEQUENTLY HAD AN ECTOPIC PREGNANCY FOLLOWED BY AN INTRAUTERINE PREGNANCY. DATE OF AND TREATMENT FOR ECTOPIC PREGNANCY ARE UNKNOWN. SECOND PREGNANCY OCCURED APPROXIMATELY IN (B)(6) 2011. (B)(6). MANUFACTURER HAS MADE NUMEROUS ATTEMPTS TO CONTACT PATIENT, BUT HAS BEEN UNABLE TO OBTAIN FURTHER INFORMATION.

    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 31 YR Required Intervention