BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7863860 · Received September 11, 2018

    Report

    Report Number
    2951250-2018-03960
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    September 11, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ESSURE POKED OUT OF THE FALLOPIAN TUBE"), GENITAL HAEMORRHAGE ("EXTREME BLEEDING") AND HEADACHE ("HEADACHE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("BACK PAIN ON THE SAME SIDE"), FATIGUE ("TIREDNESS") AND PROCEDURAL PAIN ("LEFT SIDE IS SUPER SORE, BUT MYT RIGHT SIDE IS NEAR NORMAL"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC HYSTERECTOMY), SURGERY (ABLATION OF THE UTERUS) AND SURGERY (WIDENING OF LEFT SINUS CANAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, HEADACHE, BACK PAIN, FATIGUE AND PROCEDURAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. 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
    705217 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R