BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055921 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07746
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    November 22, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("CONSTANT BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN 2013, 30 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834523 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R