[177252573]
This spontaneous case was reported by a lawyer and describes the occurrence of back pain ('back pain'), sjogren's syndrome ('sjogren's syndrome') and hallucination ('seeing halos at night') in a female patient who had essure inserted. The occurrence of additional non-serious events is detailed below. On an unknown date, the patient had essure inserted. On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), sjogren's syndrome (seriousness criterion medically significant), hallucination (seriousness criterion medically significant), arthralgia ("joint pain"), headache ("headache"), fatigue ("fatigued"), photophobia ("light sensitivity"), myalgia ("muscle pain"), eye pruritus ("itchy eyes"), dry eye ("dry eyes"), vision blurred ("blurred vision"), palpitations ("heart palpitation"), peripheral swelling ("swelling of hands and feet"), hypoaesthesia ("numbing of hands or feet"), feeling abnormal ("brain fog"), respiratory disorder ("respiratory issues"), gingival bleeding ("bleeding gums"), plicated tongue ("fissures in tongue"), candida infection ("thrush/ candidia like symptoms"), rash ("rashes/ bumps on foot"), urticaria ("hives"), rash papular ("bumps on back/foot"), pruritus ("back side with severe itching"), lymphadenopathy ("swollen glands"), pyrexia ("low grade fevers"), dyspepsia ("digestive issues") and fibromyalgia ("fibromyalgia") and was found to have antinuclear antibody positive ("ana positive"). The patient was treated with surgery (salpingectomy and hysterectomy). Essure was removed. At the time of the report, the back pain, sjogren's syndrome, hallucination, arthralgia, fatigue, photophobia, myalgia, eye pruritus, dry eye, vision blurred, palpitations, peripheral swelling, hypoaesthesia, feeling abnormal, respiratory disorder, gingival bleeding, plicated tongue, candida infection, rash, urticaria, rash papular, pruritus, lymphadenopathy, pyrexia, dyspepsia, fibromyalgia and antinuclear antibody positive outcome was unknown. The reporter considered antinuclear antibody positive, arthralgia, back pain, candida infection, dry eye, dyspepsia, eye pruritus, fatigue, feeling abnormal, fibromyalgia, gingival bleeding, hallucination, headache, hypoaesthesia, lymphadenopathy, myalgia, palpitations, peripheral swelling, photophobia, plicated tongue, pruritus, pyrexia, rash, rash papular, respiratory disorder, sjogren's syndrome, urticaria and vision blurred to be related to essure. No lot number or device sample was received in this case. At this time, we have no information suggesting that the device failed to meet its specifications. We will conduct a review of our complaint records and other non-conformances 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