BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6952078 · Received October 16, 2017

    Report

    Report Number
    2951250-2017-04772
    Event Type
    Injury
    Date Received
    October 16, 2017
    Report Date
    August 20, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MENORRHAGIA WAS RESOLVING AND THE UTERINE PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, PELVIC PAIN AND UTERINE PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY DURING WHICH BOTH HER FALLOPIAN TUBES, AND A PORTION OF THE RIGHT OVARY WERE REMOVED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2018: PFS AND MEDICAL RECORD RECEIVED: REPORTER INFORMATION, LOT NUMBER AND EVENT UTERINE PAIN WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING"), MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING") AND UTERINE PAIN ("UTERINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MENORRHAGIA WAS RESOLVING AND THE UTERINE PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA, PELVIC PAIN AND UTERINE PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY DURING WHICH BOTH HER FALLOPIAN TUBES, AND A PORTION OF THE RIGHT OVARY WERE REMOVED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT : AT THE TIME OF REPORTING, 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING") AND MENORRHAGIA ("ABNORMALLY HEAVY MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER AND MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF UNDERWENT A ROBOTIC BILATERAL SALPINGECTOMY AND PARTIAL RIGHT OOPHORECTOMY DURING WHICH BOTH HER FALLOPIAN TUBES, AND A PORTION OF THE RIGHT OVARY WERE REMOVED. 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
    730795 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R IBUPROFEN| IBUPROFEN| TYLENOL [PARACETAMOL]| TYLENOL [PARACETAMOL]