[186152053]
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('reproductive system disorder or condition type of disorder or condition pid') in an adult female patient who had essure (ess205) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test". On (b)(6) 2007, the patient had essure (ess205) inserted. On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criterion medically significant), genital haemorrhage ("general abnormal bleeding"), pelvic pain ("chronic pelvic pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), abdominal pain ("abdominal pain "), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("metrorrhagia (bleeding between periods)"), bladder disorder ("bladder problems "), urinary tract infection ("urinary tract infection "), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal conditions "), tooth disorder ("dental problems"), vaginal haemorrhage ("vaginal bleeding"), nausea ("nausea") and complication of device insertion ("she could not implant the left side with an essure coil/ procedure unsuccessful - double ligation with filshie clips") and was found to have hormone level abnormal ("hormonal changes "), weight increased ("weight gain ") and weight decreased ("weight loss"). Essure (ess205) treatment was not changed. At the time of the report, the pelvic inflammatory disease, genital haemorrhage, pelvic pain, dysmenorrhoea, abdominal pain, back pain, menorrhagia, metrorrhagia, bladder disorder, urinary tract infection, fatigue, gastrointestinal disorder, tooth disorder, hormone level abnormal, weight increased, weight decreased, vaginal haemorrhage, nausea and complication of device insertion outcome was unknown. The reporter considered abdominal pain, back pain, bladder disorder, complication of device insertion, dysmenorrhoea, fatigue, gastrointestinal disorder, genital haemorrhage, hormone level abnormal, menorrhagia, metrorrhagia, nausea, pelvic inflammatory disease, pelvic pain, tooth disorder, urinary tract infection, vaginal haemorrhage, weight decreased and weight increased to be related to essure (ess205). The reporter commented: plaintiff was unable to afford essure removal. Most recent follow-up information incorporated above includes: on (b)(6) 2020: plaintiff fact sheet received. Case became incident. Events pid , vaginal bleeding, nausea & device insertion complication added. Product, patient & reporter information updated. Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5