BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3189720 · Received June 24, 2013

    Report

    Report Number
    2951250-2013-00012
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    May 31, 2013
    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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE EXPLANT PHYSICIAN BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DR REPORTED ECTOPIC PREGNANCY ON (B)(6) 2013. UNABLE TO OBTAIN FURTHER INFORMATION ON PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284717 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention