| Model Number ESS305 |
| Device Problems
Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190)
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| Patient Problems
Autoimmune Disorder (1732); Inflammation (1932); Pain (1994); Anxiety (2328); Depression (2361); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 03/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant"), device breakage ("fracturing of implant") and autoimmune disorder ("autoimmune issues") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In april 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), dyspareunia ("pain with sex"), coital bleeding ("bleeding with sex"), pelvic pain ("pelvic pain"), inflammation ("inflammation"), depression ("depression"), anxiety ("anxiety"), dysgeusia ("metal taste") and pain ("pain").The patient was treated with surgery (essure removal) and surgery (essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, autoimmune disorder, dyspareunia, coital bleeding, pelvic pain, inflammation, depression, anxiety, dysgeusia and pain outcome was unknown.The reporter considered anxiety, autoimmune disorder, coital bleeding, depression, device breakage, device dislocation, dysgeusia, dyspareunia, inflammation, pain and pelvic pain to be related to essure.Further company follow-up with the consumer is not possible.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant"), device breakage ("fracturing of implant") and autoimmune disorder ("antoimmune issues") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), dyspareunia ("pain with sex"), coital bleeding ("bleeding with sex"), pelvic pain ("pelvic pain"), inflammation ("inflammation"), depression ("depression"), anxiety ("anxiety"), dysgeusia ("metal taste") and pain ("pain").The patient was treated with surgery (essure removal) and surgery (essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, autoimmune disorder, dyspareunia, coital bleeding, pelvic pain, inflammation, depression, anxiety, dysgeusia and pain outcome was unknown.The reporter considered anxiety, autoimmune disorder, coital bleeding, depression, device breakage, device dislocation, dysgeusia, dyspareunia, inflammation, pain and pelvic pain to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant"), device breakage ("fracturing of implant/ device breakage/ dr.Said he wasn't able to retrieve a small piece of the essure that was not connected to the main part of the essure during removal"), systemic lupus erythematosus ("autoimmune issues/ autoimmune disorder type of disorder: lupus") and pelvic pain ("pelvic pain/pain stabling pain in lower pelvic area") in a 34-year-old female patient who had essure 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 "essure confirmation test not performed".The patient's medical history included lyme disease.Current weight 145 lbs.Concurrent conditions included body mass index normal.Concomitant products included cyclobenzaprine, escitalopram oxalate (lexapro) in 2018, magnesium aspartate from 2016 to 2019, sertraline hydrochloride (zoloft) from 2016 to 2018 and sertraline from 2016 to 2018.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2013, the patient experienced nausea ("nausea"), paraesthesia ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), confusional state ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), tinnitus ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), memory impairment ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine") and feeling abnormal ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine").In march 2013, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("pain with sex/dyspareunia (painful sexual intercourse)"), depression ("psychological or psychiatric problems condition: depression/anxiety"), anxiety ("psychological or psychiatric problems condition: depression/anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue"), feeling of body temperature change ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), migraine ("migraines / headaches they were so much worse after essure"), headache ("migraines / headaches they were so much worse after essure"), photosensitivity reaction ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), dry skin ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), acne ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), cyst ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), osteoporosis ("hormonal changes describe: weak bones"), sleep disorder ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), hyperhidrosis ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), affective disorder ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), allergy to chemicals ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), perfume sensitivity ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), hypersensitivity ("allergic or hypersensitivity reaction type: hypersensitivity to smog or smell of fire"), dermatitis contact ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), stress ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones") and gluten sensitivity ("gluten sensitivity").In april 2013, the patient was found to have weight increased ("weight gain / loss(specify which one) weight gain").In (b)(6) 2014, the patient experienced irritable bowel syndrome ("gastrointestinal or digestive system condition type: irritable bowel syndrome,bloating") and abdominal distension ("gastrointestinal or digestive system condition type: irritable bowel syndrome,bloating").In (b)(6) 2014, the patient experienced chest pain ("blood or heart disorder/condition type: heart palpitations/chest pain") and palpitations ("blood or heart disorder/condition type: heart palpitations/chest pain").In (b)(6) 2015, the patient experienced ocular icterus ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed"), vision blurred ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed") and dry eye ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed").In (b)(6) 2017, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti's").On (b)(6) 2017, the patient underwent tooth repair ("dental problems sensitivity, dry mouth, fillings decaying") and experienced sensitivity of teeth ("dental problems sensitivity, dry mouth, fillings decaying"), dry mouth ("dental problems sensitivity, dry mouth, fillings decaying") and dental caries ("dental problems sensitivity, dry mouth, fillings decaying").On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required).In (b)(6) 2018, the patient was found to have benign breast neoplasm ("tumor / teratoma / cancer type: 7mm benign tumor on right breast").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), coital bleeding ("bleeding with sex"), inflammation ("inflammation"), dysgeusia ("metal taste"), abdominal pain upper ("stomach pain"), spinal pain ("middle back thoracic spine") and mood altered ("hormonal changes describe:mood level").The patient was treated with surgery (bilateral salpingectomy and salpingectomy (bilateral removal of fallopian tubes) partial bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, systemic lupus erythematosus, pelvic pain, dyspareunia, coital bleeding, inflammation, depression, anxiety, dysgeusia, vaginal haemorrhage, menorrhagia, chest pain, dysmenorrhoea, fatigue, urinary tract infection, feeling of body temperature change, migraine, headache, nausea, paraesthesia, confusional state, tinnitus, memory impairment, feeling abnormal, photosensitivity reaction, dry skin, acne, cyst, benign breast neoplasm, ocular icterus, vision blurred, dry eye, weight increased, osteoporosis, sleep disorder, hyperhidrosis, affective disorder, allergy to chemicals, perfume sensitivity, hypersensitivity, dermatitis contact, stress, palpitations, tooth repair, sensitivity of teeth, dry mouth, dental caries, irritable bowel syndrome, abdominal distension, abdominal pain upper, spinal pain, mood altered and gluten sensitivity outcome was unknown.The reporter considered abdominal distension, abdominal pain upper, acne, affective disorder, allergy to chemicals, anxiety, benign breast neoplasm, chest pain, coital bleeding, confusional state, cyst, dental caries, depression, dermatitis contact, device breakage, device dislocation, dry eye, dry mouth, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, feeling of body temperature change, gluten sensitivity, headache, hyperhidrosis, hypersensitivity, inflammation, irritable bowel syndrome, memory impairment, menorrhagia, migraine, mood altered, nausea, ocular icterus, osteoporosis, palpitations, paraesthesia, pelvic pain, perfume sensitivity, photosensitivity reaction, sensitivity of teeth, sleep disorder, spinal pain, stress, systemic lupus erythematosus, tinnitus, tooth repair, urinary tract infection, vaginal haemorrhage, vision blurred and weight increased to be related to essure.The reporter commented: in current pfs, essure insertion date is (b)(6) 2013 diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 19-apr-2019: pfs received: reporters¿ information and patient's demographic details updated.New events added- abnormal bleeding (vaginal, menorrhagia), hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes, lupus, heart palpitations, chest pain, dental problems sensitivity, dry mouth, fillings, decaying, dysmenorrhea(cramping), fatigue, irritable bowel syndrome, uti's, sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones, migraines / headaches, nausea, confusion, constant ringing of the ears, forgetfulness, tingling, sensations down my spine, depression, dry skin, acne, cysts, sun sensitivity, benign tumor on right breast, blurred vision at night, dry eyes, eye whites have yellowed, weight gain, middle back thoracic spine pain, stomach pain and device monitoring test not performed.Concomitant drugs and medical history were added.Events onset date was added.Incident- no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant'), device breakage ('fracturing of implant/ device breakage/ dr.Said he wasn't able to retrieve a small piece of the essure that was not connected to the main part of the essure during removal'), pelvic pain ('pelvic pain/pain stabling pain in lower pelvic area'), systemic lupus erythematosus ('autoimmune issues/ autoimmune disorder type of disorder: lupus') and nephrolithiasis ('kidney stone') in a 34-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "i had ablation done at the same time essure was implanted" and device monitoring procedure not performed "essure confirmation test not performed".The patient's medical history included lyme disease, uterine ablation, loss of energy, fever, shortness of breath, salpingitis, endometriosis externa and adhesiolysis.Current weight 145 lbs.Previously administered products included for an unreported indication: nuvaring from 2007 to 2009.Concurrent conditions included body mass index normal.Concomitant products included cyclobenzaprine, escitalopram oxalate (lexapro) in 2018, magnesium aspartate (megamag) from 2016 to 2019, sertraline hydrochloride (zoloft) from 2016 to 2018 and sertraline from 2016 to 2018.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2013, the patient experienced nausea ("nausea"), paraesthesia ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), confusional state ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), tinnitus ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine"), memory impairment ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine") and feeling abnormal ("neurological conditions or problems type: confusion, brain fog, constant ringing of the ears, forgetfulness, tingling sensations down my spine").In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), systemic lupus erythematosus (seriousness criterion medically significant), dyspareunia ("pain with sex/dyspareunia (painful sexual intercourse)"), depression ("psychological or psychiatric problems condition: depression/anxiety"), anxiety ("psychological or psychiatric problems condition: depression/anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)"), fatigue ("fatigue"), feeling of body temperature change ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), migraine ("migraines / headaches they were so much worse after essure"), headache ("migraines / headaches they were so much worse after essure"), photosensitivity reaction ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), dry skin ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), acne ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), cyst ("rashes or skin conditions type: dry skin,acne, cysts, sun sensitivity"), osteoporosis ("hormonal changes describe: weak bones"), sleep disorder ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), hyperhidrosis ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), affective disorder ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones"), allergy to chemicals ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), perfume sensitivity ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), hypersensitivity ("allergic or hypersensitivity reaction type: hypersensitivity to smog or smell of fire"), dermatitis contact ("allergic or hypersensitivity reaction type: hypersensitivity to chemicals in any cleaning, cosmetics and smog or the smell of fire, candles and perfumes"), stress ("hormonal changes describe: sleep cycles, mood and stress levels, body temperature, unexplained sweating, weak bones") and gluten sensitivity ("gluten sensitivity").In (b)(6) 2013, the patient was found to have weight increased ("weight gain / loss(specify which one) weight gain").In (b)(6) 2014, the patient experienced irritable bowel syndrome ("gastrointestinal or digestive system condition type: irritable bowel syndrome,bloating") and abdominal distension ("gastrointestinal or digestive system condition type: irritable bowel syndrome,bloating").In (b)(6) 2014, the patient experienced angina pectoris ("blood or heart disorder/condition type: heart palpitations/chest pain") and palpitations ("blood or heart disorder/condition type: heart palpitations/chest pain").In (b)(6) 2015, the patient experienced ocular icterus ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed"), vision blurred ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed") and dry eye ("vision/eye problems type: blurred vision at night, dry eyes, eye whites have yellowed").In (b)(6) 2017, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti's").On (b)(6) 2017, the patient underwent tooth repair ("dental problems sensitivity, dry mouth, fillings decaying") and experienced hyperaesthesia teeth ("dental problems sensitivity, dry mouth, fillings decaying"), dry mouth ("dental problems sensitivity, dry mouth, fillings decaying") and dental caries ("dental problems sensitivity, dry mouth, fillings decaying").On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required).In (b)(6) 2018, the patient was found to have benign breast neoplasm ("tumor / teratoma / cancer type: 7mm benign tumor on right breast").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), coital bleeding ("bleeding with sex"), inflammation ("inflammation"), dysgeusia ("metal taste"), abdominal pain upper ("stomach pain"), spinal pain ("middle back thorasic spine"), mood altered ("hormonal changes describe:mood level"), mood swings ("mood swings"), panic attack ("panic attack"), back pain ("constant back pain"), allergy to metals ("nickel allergy"), musculoskeletal pain ("shoulder pain is the worst pain ever"), malaise ("sickning"), nephrolithiasis (seriousness criterion medically significant), blister ("blisters"), burning sensation ("burning in my gut") and procedural pain ("the dr tried pushing it through deeper into my uterus but it hurt like hell.").The patient was treated with surgery (bilateral salpingectomy and salpingectomy (bilateral removal of fallopian tubes) partial bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, pelvic pain, systemic lupus erythematosus, dyspareunia, coital bleeding, inflammation, depression, anxiety, dysgeusia, vaginal haemorrhage, menorrhagia, angina pectoris, dysmenorrhoea, urinary tract infection, feeling of body temperature change, migraine, headache, nausea, paraesthesia, confusional state, tinnitus, memory impairment, feeling abnormal, photosensitivity reaction, dry skin, acne, cyst, benign breast neoplasm, ocular icterus, vision blurred, dry eye, osteoporosis, sleep disorder, hyperhidrosis, affective disorder, allergy to chemicals, perfume sensitivity, hypersensitivity, dermatitis contact, stress, palpitations, tooth repair, hyperaesthesia teeth, dry mouth, dental caries, irritable bowel syndrome, abdominal pain upper, spinal pain, mood altered, gluten sensitivity, mood swings, panic attack, back pain, allergy to metals, malaise, nephrolithiasis, blister, burning sensation and procedural pain outcome was unknown, the fatigue and weight increased was resolving and the abdominal distension had resolved.The reporter considered abdominal distension, abdominal pain upper, acne, affective disorder, allergy to chemicals, allergy to metals, angina pectoris, anxiety, back pain, benign breast neoplasm, blister, burning sensation, coital bleeding, confusional state, cyst, dental caries, depression, dermatitis contact, device breakage, device dislocation, dry eye, dry mouth, dry skin, dysgeusia, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, feeling of body temperature change, gluten sensitivity, headache, hyperaesthesia teeth, hyperhidrosis, hypersensitivity, inflammation, irritable bowel syndrome, malaise, memory impairment, menorrhagia, migraine, mood altered, mood swings, musculoskeletal pain, nausea, nephrolithiasis, ocular icterus, osteoporosis, palpitations, panic attack, paraesthesia, pelvic pain, perfume sensitivity, photosensitivity reaction, procedural pain, sleep disorder, spinal pain, stress, systemic lupus erythematosus, tinnitus, tooth repair, urinary tract infection, vaginal haemorrhage, vision blurred and weight increased to be related to essure.The reporter commented: in current pfs, essure insertion date is (b)(6) 2013.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain.Concerning the injuries reported in this case, the following ones were described in patient¿s social media records: gluten sensitivity, dermatitis contact, vision issues, migraine/headache, dry eyes, abdominal distension, ocular icterus, mood swings, urinary tract infection, anxiety, tinnitus, depression, systemic lupus erythematous, abdominal pain upper, spinal pain, fatigue, weight gain, back pain, panic attack, allergy to metals and musculoskeletal pain".Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 12-nov-2019: social media record received.Events" i had ablation done at the same time essure was implanted, mood swings, panic attack, constant back pain, nickel allergy and shoulder pain is the worst pain ever were added.Reporter was added.No lot number or device sample was received in this case.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.
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