[186508117]
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / chronic pain') in an adult female patient who had essure (batch no. 627451) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device ineffective "device ineffective" and device monitoring procedure not performed "confirmation test not conducted". The patient's medical history included parity 4 (dates of live births: (b)(6) 1994, (b)(6) 1995, (b)(6) 2001, (b)(6) 2009. ). Bad bleeding and clotting at 5 months, miscarriage. On (b)(6) 2009, the patient had essure inserted. In (b)(6) 2011, the patient was found to have a pregnancy with contraceptive device ("pregnant"). On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), abdominal pain ("abdominal pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)") and adnexa uteri pain ("ovarian pain"). The patient was treated with surgery (surgical removal of coils). Essure was removed. At the time of the report, the pelvic pain, abdominal pain, menorrhagia and pregnancy with contraceptive device outcome was unknown and the genital haemorrhage, dysmenorrhoea and adnexa uteri pain had resolved. Pregnancy related information: retrospective report. Last menstrual period and estimated date of delivery were not provided. Potential fetal exposure to essure occurred during the first trimester. The pregnancy outcome was reported as elective abortion. The reporter considered abdominal pain, adnexa uteri pain, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic pain and pregnancy with contraceptive device to be related to essure. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: unilateral occlusion (left tube occluded). Quality-safety evaluation of ptc: unable to confirm complaint. Further company follow-up with the lawyer or lawyer is not possible. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received: case become incident, lot number, events: ovarian pain, pregnancy, device ineffective were added. Reporter, lab data were added. We received a lot number in this case. A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5