| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Dyspnea (1816); Emotional Changes (1831); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Skin Irritation (2076); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Hot Flashes/Flushes (2153); Tingling (2171); Twitching (2172); Dizziness (2194); Neurogenic Shock (2265); Urinary Frequency (2275); Depression (2361); Numbness (2415); Sweating (2444); Shaking/Tremors (2515); Cognitive Changes (2551); Confusion/ Disorientation (2553); Abdominal Distention (2601); Heavier Menses (2666); Constipation (3274)
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (us food and drug administration, reference number: mw5074868) on 16-feb-2018.The most recent information was received on 07-mar-2018.This spontaneous case was reported by an other and describes the occurrence of abdominal pain lower ("cramping"), suicidal ideation ("suicidal thoughts"), neurogenic shock ("brain shocks") and depression suicidal ("depression( sadness/ suicidal thoughts)") in a female patient who had essure (batch no.675112) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included lactobacillus reuteri (probiotica), salbutamol (ventolin) and stelamin (plexus).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced menorrhagia ("excessive bleeding during period").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), neurogenic shock (seriousness criterion medically significant), depression suicidal (seriousness criterion medically significant), feeling abnormal ("brain fog"), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), vaginal discharge ("discharge"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), the first episode of gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating"), dyspepsia ("heartburn"), the second episode of gastrointestinal disorder ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)"), dizziness ("dizziness"), the first episode of paraesthesia ("tingling sensation"), depressed level of consciousness ("cloudiness"), memory impairment ("forgetfulness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), the second episode of paraesthesia ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), night sweats ("night sweats"), loss of libido ("loss of libido"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), migraine ("migraine"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity") and food allergy ("food sensitivities").At the time of the report, the abdominal pain lower, suicidal ideation, neurogenic shock, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, premature menopause, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, dyspepsia, the last episode of gastrointestinal disorder, headache, tinnitus, dizziness, depressed level of consciousness, memory impairment, anxiety, panic attack, mood swings, cognitive disorder, hypoaesthesia, the last episode of paraesthesia, tremor, fatigue, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, migraine, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity and food allergy outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, the first episode of gastrointestinal disorder, the first episode of paraesthesia, the second episode of gastrointestinal disorder and the second episode of paraesthesia with essure.The reporter considered headache to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.Most recent follow-up information incorporated above includes: on 7-mar-2018: as per company internal coding review, the event brain shocks was re-coded to meddra llt neurogenic shock, the event brain fog was coded to meddra llt mental impairment , event urgent frequent urination was splited to meddra llt frequency urinary and urgency urination.Follow up 1 ,follow up 2 ,follow up 3 processed together.On 7-mar-2018: follow up 1 ,follow up 2 ,follow up 3 processed together.On 7-mar-2018: follow up 1 ,follow up 2 ,follow up 3 processed together.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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (us food and drug administration, reference number: mw5074868) on 16-feb-2018.The most recent information was received on 17-dec-2018.This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ("cramping"), suicidal ideation ("suicidal thoughts"), neurogenic shock ("brain shocks") and depression suicidal ("depression( sadness/ suicidal thoughts)") in a female patient who had essure (batch no: 675112) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included (), lactobacillus reuteri (probiotica) and salbutamol.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced menorrhagia ("excessive bleeding during period").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), neurogenic shock (seriousness criterion medically significant), depression suicidal (seriousness criterion medically significant), feeling abnormal ("brain fog"), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), vaginal discharge ("discharge"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), the first episode of gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating"), dyspepsia ("heartburn"), the second episode of gastrointestinal disorder ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)"), dizziness ("dizziness"), the first episode of paraesthesia ("tingling sensation"), depressed level of consciousness ("cloudiness"), memory impairment ("forgetfullness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), the second episode of paraesthesia ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), night sweats ("night sweats"), loss of libido ("loss of libido"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), migraine ("migraine"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity"), food allergy ("food sensitivities") and injury ("injury").At the time of the report, the abdominal pain lower, suicidal ideation, neurogenic shock, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, premature menopause, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, dyspepsia, the last episode of gastrointestinal disorder, headache, tinnitus, dizziness, depressed level of consciousness, memory impairment, anxiety, panic attack, mood swings, cognitive disorder, hypoaesthesia, the last episode of paraesthesia, tremor, fatigue, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, migraine, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity, food allergy and injury outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, the first episode of gastrointestinal disorder, the first episode of paraesthesia, the second episode of gastrointestinal disorder and the second episode of paraesthesia with essure.The reporter considered headache and injury to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-dec-2018: summon received- lawyer added, case became potential legal.Event injury added.Incident: 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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (us food and drug administration, reference number: mw5074868) on 16-feb-2018.The most recent information was received on 17-sep-2018.This spontaneous case was reported by an other and describes the occurrence of abdominal pain lower ("cramping"), suicidal ideation ("suicidal thoughts"), neurogenic shock ("brain shocks") and depression suicidal ("depression( sadness/ suicidal thoughts)") in a female patient who had essure (batch no.675112) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included lactobacillus reuteri (probiotica), salbutamol (ventolin) and stelamin (plexus).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced menorrhagia ("excessive bleeding during period").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), neurogenic shock (seriousness criterion medically significant), depression suicidal (seriousness criterion medically significant), feeling abnormal ("brain fog"), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), vaginal discharge ("discharge"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), the first episode of gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating"), dyspepsia ("heartburn"), the second episode of gastrointestinal disorder ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)"), dizziness ("dizziness"), the first episode of paraesthesia ("tingling sensation"), depressed level of consciousness ("cloudiness"), memory impairment ("forgetfullness"), anxiety ("anxiety"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), the second episode of paraesthesia ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), night sweats ("night sweats"), loss of libido ("loss of libido"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), migraine ("migraine"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity") and food allergy ("food sensitivities").At the time of the report, the abdominal pain lower, suicidal ideation, neurogenic shock, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, premature menopause, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, abdominal pain, nausea, vomiting, constipation, diarrhoea, abdominal distension, dyspepsia, the last episode of gastrointestinal disorder, headache, tinnitus, dizziness, depressed level of consciousness, memory impairment, anxiety, panic attack, mood swings, cognitive disorder, hypoaesthesia, the last episode of paraesthesia, tremor, fatigue, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, migraine, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity and food allergy outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, the first episode of gastrointestinal disorder, the first episode of paraesthesia, the second episode of gastrointestinal disorder and the second episode of paraesthesia with essure.The reporter considered headache to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-sep-2018: quality safety evaluation of 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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (us food and drug administration, reference number: mw5074868) on 16-feb-2018.The most recent information was received on 22-nov-2019.This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('cramping'), suicidal ideation ('suicidal thoughts'), neurogenic shock ('brain shocks / nuero condit/prob') and depression suicidal ('depression( sadness/ suicidal thoughts)') in a 41-year-old female patient who had essure (batch no.675112) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, pelvic pain and pelvic adhesions.Concomitant products included ascorbic acid;bioflavonoids nos;magnesium hydroxide;sodium bicarbonate (plexus bio cleanse), lactobacillus reuteri (probiotica) and salbutamol.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2010, the patient experienced menorrhagia ("excessive bleeding during period/ abnormal bleeding (menorrhagia) / menorrhagia (heavy menstrual bleeding)"), 1 month 1 day after insertion of essure.In (b)(6) 2010, the patient experienced hypersensitivity ("allergic or hypersensitivity reaction type: became allergic to everything").In (b)(6) 2010, the patient experienced vaginal discharge ("discharge/ vaginal discharge"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)/ nickel allergy"), migraine ("migraine/ migraines / headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), pelvic pain ("pelvic pain") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2012, the patient experienced feeling abnormal ("brain fog/ neurological conditions or problems type: brain fog"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating/ bloating"), memory impairment ("forgetfulness/ memory issues"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs"), alopecia ("hair loss") and visual impairment ("vision/eye problems type: vision progressively got worse") and was found to have weight increased ("weight gain").In 2013, the patient experienced anxiety ("anxiety/ psychiatric problems condition: anxiety") and depression ("depression").In (b)(6) 2016, the patient experienced night sweats ("night sweats") and loss of libido ("loss of libido/ hormonal changes describe: loss of libido").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), neurogenic shock (seriousness criterion medically significant), depression suicidal (seriousness criterion medically significant), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), dyspepsia ("heartburn"), other disorders of intestine ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)/ tinnitus"), dizziness ("dizziness"), tingling sensation ("tingling sensation"), depressed level of consciousness ("cloudiness"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), tingling feet/hands ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity"), food allergy ("food sensitivities/ allergies were constant and year round - issues with foods as well"), injury ("injury"), chronic sinusitis ("sinus from chronic sinusitis/allergies - was told after it was not effective that allergies were the issue and necessary to treat that before having another surgery"), arthralgia ("joint pain") and sleep apnoea syndrome ("sleep apnea").The patient was treated with surgery (hysterectomy.(full), salpingectomy (bilateral)).Essure was removed on (b)(6) 2018.At the time of the report, the abdominal pain lower, suicidal ideation, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, vomiting, constipation, diarrhoea, abdominal distension, dyspepsia, other disorders of intestine, tinnitus, dizziness, tingling sensation, depressed level of consciousness, memory impairment, panic attack, cognitive disorder, hypoaesthesia, tingling feet/hands, tremor, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity, food allergy, injury, vaginal haemorrhage, hypersensitivity and sleep apnoea syndrome outcome was unknown, the neurogenic shock, premature menopause, abdominal pain, gastrointestinal disorder, nausea, headache, mood swings, fatigue, migraine, depression, weight increased, alopecia, pelvic pain, dysmenorrhoea, visual impairment, chronic sinusitis and arthralgia had resolved and the anxiety and irritable bowel syndrome was resolving.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gastrointestinal disorder, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tingling sensation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, other disorders of intestine and tingling feet/hands with essure.The reporter considered alopecia, arthralgia, chronic sinusitis, depression, dysmenorrhoea, headache, hypersensitivity, injury, irritable bowel syndrome, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage, visual impairment and weight increased to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.It was reported that right: 2 coils and left: 4 coils.It was reported that dense right-sided adhesions of uterus to anterior abdominal wall.Discrepancy noted in essure insertion date (b)(6) 2010 and (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76.19 kgs.Hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-nov-2019: pfs received: event outcome were updated of previously added events.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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (us food and drug administration, reference number: (b)(4) on 16-feb-2018.The most recent information was received on 17-sep-2019.This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('cramping'), suicidal ideation ('suicidal thoughts'), neurogenic shock ('brain shocks') and depression suicidal ('depression( sadness/ suicidal thoughts)') in a 41-year-old female patient who had essure (batch no.675112) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, pelvic pain and pelvic adhesions.Concomitant products included lactobacillus reuteri (probiotica), other nutrients and salbutamol.On (b)(6)2010, the patient had essure inserted.On (b)(6)2010, the patient experienced menorrhagia ("excessive bleeding during period/ abnormal bleeding (menorrhagia)").In (b)(6)2010, the patient experienced hypersensitivity ("allergic or hypersensitivity reaction type: became allergic to everything").In (b)(6)2010, the patient experienced vaginal discharge ("discharge/ vaginal discharge"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)/ nickel allergy"), migraine ("migraine/ migraines / headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), pelvic pain ("pelvic pain") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2012, the patient experienced feeling abnormal ("brain fog/ neurological conditions or problems type: brain fog"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating/ bloating"), memory impairment ("forgetfulness/ memory issues"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs"), alopecia ("hair loss") and visual impairment ("vision/eye problems type: vision progressively got worse") and was found to have weight increased ("weight gain").In 2013, the patient experienced anxiety ("anxiety/ psychiatric problems condition: anxiety") and depression ("depression").In (b)(6)2016, the patient experienced night sweats ("night sweats") and loss of libido ("loss of libido/ hormonal changes describe: loss of libido").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation (seriousness criterion medically significant), neurogenic shock (seriousness criterion medically significant), depression suicidal (seriousness criterion medically significant), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), dyspepsia ("heartburn"), other disorders of intestine ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)/ tinitis"), dizziness ("dizziness"), tingling sensation ("tingling sensation"), depressed level of consciousness ("cloudiness"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), tingling feet/hands ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity"), food allergy ("food sensitivities/ allergies were constant and year round - issues with foods as well"), injury ("injury"), chronic sinusitis ("sinus from chronic sinusitis/allergies - was told after it was not effective that allergies were the issue and necessary to treat that before having another surgery"), arthralgia ("joint pain") and sleep apnoea syndrome ("sleep apnea").The patient was treated with surgery (da vinci assisted total laparoscopic hysterectomy and bilateral salpingectomies.Lysis of adhesions).Essure was removed on (b)(6)2018.At the time of the report, the abdominal pain lower, suicidal ideation, neurogenic shock, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, abdominal pain, gastrointestinal disorder, nausea, vomiting, constipation, diarrhoea, abdominal distension, dyspepsia, other disorders of intestine, headache, tinnitus, dizziness, tingling sensation, depressed level of consciousness, memory impairment, panic attack, mood swings, cognitive disorder, hypoaesthesia, tingling feet/hands, tremor, fatigue, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, migraine, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity, food allergy, injury, vaginal haemorrhage, weight increased, alopecia, pelvic pain, dysmenorrhoea, visual impairment, hypersensitivity and sleep apnoea syndrome outcome was unknown, the premature menopause, depression, chronic sinusitis and arthralgia had resolved and the anxiety and irritable bowel syndrome was resolving.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gastrointestinal disorder, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tingling sensation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, other disorders of intestine and tingling feet/hands with essure.The reporter considered alopecia, arthralgia, chronic sinusitis, depression, dysmenorrhoea, headache, hypersensitivity, injury, irritable bowel syndrome, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage, visual impairment and weight increased to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.It was reported that right: 2 coils and left: 4 coils.It was reported that dense right-sided adhesions of uterus to anterior abdominal wall.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76.19 kgs.Hysterosalpingogram - on (b)(6)2010: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-sep-2019: follow up 6 and 7 processed togetherlaboratory data added.Added event abnormal bleeding (vaginal), depression, weight increased, gastrointestinal or digestive system condition type: ibs, hair loss, pain, dysmenorrhea (cramping), vision/eye problems type: vision progressively got worse, sinus from chronic sinusitis/allergies - was told after it was not effective that allergies were the issue and necessary to treat that before having another surgery, allergic or hypersensitivity reaction type: became allergic to everything.Updated reported events loss of libido, menorrhagia, anxiety, migraine, feeling abnormal, tinnitus, allergy to metals, vaginal discharge, abdominal distension, memory impairment, food allergy, joint pain, abdominal pain.Updated event outcome, onset dates.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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (us food and drug administration, reference number: mw5074868) on 16-feb-2018.The most recent information was received on 23-mar-2020.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('cramping') in a 41-year-old female patient who had essure (batch no.675112) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, pelvic pain and pelvic adhesions.Concomitant products included ascorbic acid;bioflavonoids nos;magnesium hydroxide;sodium bicarbonate (plexus bio cleanse), lactobacillus reuteri (probiotica) and salbutamol.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2010, the patient experienced menorrhagia ("excessive bleeding during period/ abnormal bleeding (menorrhagia) / menorrhagia (heavy mentsrual bleeding)"), 1 month 1 day after insertion of essure.In (b)(6) 2010, the patient experienced hypersensitivity ("allergic or hypersensitivity reaction type: became allergic to everything").In (b)(6) 2010, the patient experienced vaginal discharge ("discharge/ vaginal discharge"), fatigue ("fatigue"), allergy to metals ("metal allergy (nickel)/ nickel allergy"), migraine ("migraine/ migraines / headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), pelvic pain ("pelvic pain") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2012, the patient experienced feeling abnormal ("brain fog/ neurological conditions or problems type: brain fog"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating/ bloating"), memory impairment ("forgetfullness/ memory issues"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs"), alopecia ("hair loss") and visual impairment ("vision/eye problems type: vision progressively got worse") and was found to have weight increased ("weight gain").In 2013, the patient experienced anxiety ("anxiety/ psychiatric problems condition: anxiety") and depression ("depression").In (b)(6) 2016, the patient experienced night sweats ("night sweats") and loss of libido ("loss of libido/ hormonal changes describe: loss of libido").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), suicidal ideation ("suicidal thoughts"), neurogenic shock ("brain shocks / nuero condit/prob"), depression suicidal ("depression( sadness/ suicidal thoughts)"), polymenorrhoea ("long menstrual cycle(polymenorrhea)"), premature menopause ("early menopause symptoms"), hot flush ("hot flashes"), incontinence ("incontinence"), vulvovaginal candidiasis ("yeast infection (candida)"), pollakiuria ("urgent frequent urination"), micturition urgency ("urgent frequent urination"), vulvovaginal pruritus ("itching"), vulvovaginal burning sensation ("burning"), vulvovaginal pain ("stinging, stabbing of vaginal entrance"), breast pain ("breast pain"), breast tenderness ("tenderness"), abdominal rigidity ("abdominal spasm"), abdominal pain ("abdominal twitching fluttering"), gastrointestinal disorder ("gastrointestinal"), nausea ("nausea"), vomiting ("vomiting"), constipation ("constipation"), dyspepsia ("heartburn"), other disorders of intestine ("bowel issues"), headache ("headache"), tinnitus ("ringing in ears( pulsatile tinnitus)/ tinitis/volume is lower and not as high pitched"), dizziness ("dizziness"), tingling sensation ("tingling sensation"), depressed level of consciousness ("cloudiness"), panic attack ("panic attacks"), mood swings ("mood swings"), cognitive disorder ("diminished brain function"), hypoaesthesia ("numbness in hands/ feet"), tingling feet/hands ("tingling in extremities( hands/ feet)/ ticking or pricking of skin"), tremor ("tremors/ shakiness"), gluten sensitivity ("gluten sensitivity"), skin irritation ("skin irritation/ itching"), burning sensation ("burning sensation"), menstrual disorder ("abnormal menses"), coital bleeding ("bleeding/spotting after sex"), pain ("all over body aches/pain"), flatulence ("gas"), confusional state ("confusion"), amnesia ("short term memory loss"), depressed mood ("sadness"), chronic fatigue syndrome ("chronic fatigue syndrome"), multiple chemical sensitivity ("chemical sensitivity"), food allergy ("food sensitivities/ allergies were constant and year round - issues with foods as well"), injury ("injury"), chronic sinusitis ("sinus from chronic sinusitis/allergies - was told after it was not effective that allergies were the issue and necessary to treat that before having another surgery"), arthralgia ("joint pain"), sleep apnoea syndrome ("sleep apnea") and post procedural haemorrhage ("minimal bleeding after hysterectomy") and was found to have weight decreased ("i have lost weight").The patient was treated with surgery (hysterectomy.(full), salpingectomy (bilateral)).Essure was removed on (b)(6) 2018.At the time of the report, the abdominal pain lower, suicidal ideation, depression suicidal, feeling abnormal, polymenorrhoea, menorrhagia, vaginal discharge, hot flush, incontinence, vulvovaginal candidiasis, pollakiuria, micturition urgency, vulvovaginal pruritus, vulvovaginal burning sensation, vulvovaginal pain, breast pain, breast tenderness, abdominal rigidity, vomiting, constipation, diarrhoea, dyspepsia, other disorders of intestine, dizziness, tingling sensation, depressed level of consciousness, memory impairment, panic attack, cognitive disorder, hypoaesthesia, tingling feet/hands, tremor, allergy to metals, gluten sensitivity, skin irritation, burning sensation, menstrual disorder, night sweats, loss of libido, coital bleeding, pain, flatulence, confusional state, amnesia, depressed mood, chronic fatigue syndrome, multiple chemical sensitivity, food allergy, injury, vaginal haemorrhage, hypersensitivity, sleep apnoea syndrome and post procedural haemorrhage outcome was unknown, the neurogenic shock, premature menopause, abdominal pain, gastrointestinal disorder, nausea, abdominal distension, headache, mood swings, fatigue, migraine, depression, weight increased, alopecia, pelvic pain, dysmenorrhoea, visual impairment, chronic sinusitis, arthralgia and weight decreased had resolved and the tinnitus, anxiety and irritable bowel syndrome was resolving.The reporter provided no causality assessment for abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, allergy to metals, amnesia, anxiety, breast pain, breast tenderness, burning sensation, chronic fatigue syndrome, cognitive disorder, coital bleeding, confusional state, constipation, depressed level of consciousness, depressed mood, depression suicidal, diarrhoea, dizziness, dyspepsia, fatigue, feeling abnormal, flatulence, food allergy, gastrointestinal disorder, gluten sensitivity, hot flush, hypoaesthesia, incontinence, loss of libido, memory impairment, menorrhagia, menstrual disorder, micturition urgency, migraine, mood swings, multiple chemical sensitivity, nausea, neurogenic shock, night sweats, pain, panic attack, pollakiuria, polymenorrhoea, premature menopause, skin irritation, suicidal ideation, tingling sensation, tinnitus, tremor, vaginal discharge, vomiting, vulvovaginal burning sensation, vulvovaginal candidiasis, vulvovaginal pain, vulvovaginal pruritus, other disorders of intestine and tingling feet/hands with essure.The reporter considered alopecia, arthralgia, chronic sinusitis, depression, dysmenorrhoea, headache, hypersensitivity, injury, irritable bowel syndrome, pelvic pain, post procedural haemorrhage, sleep apnoea syndrome, vaginal haemorrhage, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: an intervention was mentioned but not specified and/or assigned to one of the events.Patient took amberen for menopause relief, slim, focus and energy, amen daily health brain and body power and attention support.It was reported that right: 2 coils and left: 4 coils.It was reported that dense right-sided adhesions of uterus to anterior abdominal wall.Discrepancy noted in essure insertion date (b)(6) 2010 and (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76.19 kgs.Hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion.Concerning the injuries reported in this case, the following one was described in patient¿s social media: weight decreased and abdominal distension.Most recent follow-up information incorporated above includes: on 23-mar-2020: all information related to reporters, events, source documents and reference section from deletion case: (b)(4) was added to this case.Event added: i have lost weight.Information from social media received.Added new reporters.Post procedural bleeding was added as a new event.Added outcome to tinnitus.On 23-mar-2020: information from social media received.Added new reporter.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.
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