| Model Number ESS205 |
| Device Problem
Break (1069)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Visual Disturbances (2140); Anxiety (2328); Arthralgia (2355); Depression (2361); Abdominal Cramps (2543); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165); Cancer (3262)
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| Event Date 01/01/2006 |
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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 breakage ("device breakage"), pelvic pain ("pain: pelvic pain"), genital haemorrhage ("abnormal bleeding (general)"), adenosquamous cell carcinoma ("tumor/teratoma/cancer type: squamous cell") and basedow's disease ("autoimmune disorder: graves") in a (b)(6) female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's past medical history included thyroid disorder nos, psychiatric disorder nos, graves' disease in 2002, genital bleeding, rash and visual disturbance.Concurrent conditions included body mass index normal.Concomitant products included esomeprazole magnesium (nexium), hydroxyzine, levothyroxine sodium (synthroid), quetiapine and sertraline.In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2006, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid function test abnormal ("hormonal changes describe- thyroid"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight increased ("weight gain") and irritable bowel syndrome ("gastrointestinal and digestive system condition").In 2008, the patient experienced migraine ("migraines"), headache ("headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant) and rash ("rashes or skin conditions: rash").In 2010, the patient experienced bladder disorder ("bladder problems") and urinary tract disorder ("urinary problems").In 2015, the patient experienced adenosquamous cell carcinoma (seriousness criterion medically significant).On an unknown date, the patient experienced basedow's disease (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth disorder ("dental problems"), vaginal discharge ("vaginal discharge"), arthralgia ("joint pain"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), blood oestrogen abnormal ("hormonal changes describe: estrogen"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), eye disorder ("eye problem") and post-traumatic stress disorder ("ptsd: post-traumatic stress disorder").The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oophorectomy) and surgery (hysterectomy (full) with bilateral salpingo-oophorectomy).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, bladder disorder, urinary tract disorder, migraine, headache, blood disorder, cardiac disorder, nausea, tooth disorder, dysmenorrhoea, dyspareunia, vaginal discharge, fatigue, irritable bowel syndrome, alopecia, arthralgia, neuralgia, blood oestrogen abnormal, anxiety, visual impairment, eye disorder and post-traumatic stress disorder outcome was unknown and the weight increased had resolved.The reporter considered adenosquamous cell carcinoma, alopecia, anxiety, arthralgia, basedow's disease, bladder disorder, blood disorder, blood oestrogen abnormal, calcium metabolism disorder, cardiac disorder, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, eye disorder, fatigue, female sexual dysfunction, genital haemorrhage, headache, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pelvic pain, post-traumatic stress disorder, rash, thyroid function test abnormal, tooth disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, visual impairment and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Current weight (b)(6).Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs received.Reporter information and patient's demographic updated.Historical and concurrent condition and concomitant medication added.Essure indication, lot number added.Event: severe physical injuries were updated with specific events: device breakage, pain: pelvic pain, abnormal bleeding (general), hormonal changes describe- thyroid, abnormal bleeding (vaginal), menorrhagia, apareunia (inability to have sexual intercourse), depression, autoimmune disorder: graves, rashes or skin conditions: rash, bladder problems, urinary problems, migraines, headaches, blood or heart disorder/condition type: unspecified, nausea, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), tumor/teratoma/cancer type: squamous cell, vaginal discharge, fatigue, weight gain, gastrointestinal and digestive system condition, hair loss, joint pain, nerve pain, allergies to antibiotics/medicinal allergy, hormonal changes describe: estrogen, anxiety, calcium, vision eye problem, eye problem, ptsd: post-traumatic stress disorder.She had recovered for events: weight gain.She did not undergo essure confirmation test.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage :a piece of blank fishing line came out of my breast"), pelvic pain ("pain: pelvic pain"), genital haemorrhage ("abnormal bleeding (general)"), squamous cell carcinoma of the vulva ("tumor/treatoma/cancer type: squamous cell vulvar"), adenosquamous cell carcinoma ("tumor/teratoma/cancer type: squamous cell"), basedow's disease ("autoimmune disorder: graves") and vaginal cancer ("tumor/treatoma /cancer type: vaginal entrance") in a 41-year-old female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's past medical history included thyroid disorder, psychiatric disorder nos, graves' disease in 2002, genital bleeding, rash, visual disturbance, mood swings and hot flushes.Concurrent conditions included body mass index normal, uterine tenderness, paratubal cyst, polycystic ovary and hormonal imbalance.Concomitant products included bactrim (mortin), esomeprazole magnesium (nexium), hydroxyzine, levothyroxine sodium (synthroid), naproxen sodium (aleve), oral contraceptive nos, quetiapine and sertraline.In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and endometriosis ("endometriosis").On (b)(6) 2006, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid function test abnormal ("hormonal changes describe- thyroid"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping) sharp and pinching pain, long lasting periods with severe cramps"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight increased ("weight gain"), irritable bowel syndrome ("gastrointestinal and digestive system condition"), arthralgia ("joint pain"), sneezing ("sneezing") and fungal infection ("uti's: yeast infection").In 2008, the patient experienced migraine ("migraines"), headache ("headaches : severe throbbing headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), rash ("rashes or skin conditions: rash") and hidradenitis ("rashesh or skin condition :hidradenitis").In 2010, the patient experienced urinary incontinence ("bladder problems: week bladder"), stress urinary incontinence ("urinary problems :stress incontinence"), blood oestrogen abnormal ("hormonal changes describe: estrogen") and cough ("coughing").In 2015, the patient experienced adenosquamous cell carcinoma (seriousness criterion medically significant).On an unknown date, the patient experienced squamous cell carcinoma of the vulva (seriousness criterion medically significant), basedow's disease (seriousness criterion medically significant), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth fracture ("dental problems : teeth are crumbling"), vaginal discharge ("vaginal discharge"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), vitreous floaters ("eye problem :black dots in pheripheral vision"), post-traumatic stress disorder ("ptsd: post-traumatic stress disorder"), amnesia ("short term memory loss"), back pain ("excessive back pain"), bacterial infection ("uti's:bacterial infection"), photopsia ("vision problem /eye problem: trails of light") and vaginal cancer (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oopherectomy) and surgery (hysterectomy (full) with bilateral salpingo-oopherectomy).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, squamous cell carcinoma of the vulva, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, urinary incontinence, stress urinary incontinence, migraine, headache, blood disorder, cardiac disorder, nausea, tooth fracture, dysmenorrhoea, vaginal discharge, fatigue, irritable bowel syndrome, neuralgia, blood oestrogen abnormal, anxiety, post-traumatic stress disorder, amnesia, endometriosis, sneezing, cough, back pain, fungal infection, bacterial infection, hidradenitis, photopsia and vaginal cancer outcome was unknown and the dyspareunia, weight increased, alopecia, arthralgia, visual impairment and vitreous floaters had resolved.The reporter considered adenosquamous cell carcinoma, alopecia, amnesia, anxiety, arthralgia, back pain, bacterial infection, basedow's disease, blood disorder, blood oestrogen abnormal, calcium metabolism disorder, cardiac disorder, cough, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, fungal infection, genital haemorrhage, headache, hidradenitis, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pelvic pain, photopsia, post-traumatic stress disorder, rash, sneezing, squamous cell carcinoma of the vulva, stress urinary incontinence, thyroid function test abnormal, tooth fracture, urinary incontinence, vaginal cancer, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters and weight increased to be related to essure (ess205).The reporter commented: insertion details: device placed left with 5 coils trailing.Right 4 coils trailing.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Current weight 170 lbs.On (b)(6) 2010 pathology test revealed, endo· and ectocervix with squamous metaplasia, and acute and chronic cervicitis.Secretory endometrium.Secretory endometrium.Unremarkable myometrium.Para tubal cysts.Polycystic ovaries consistent with polycystic ovary syndrome.Oviducts contain an embedded metallic device (prior sterilization procedure).No malignancy identified.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: cramping with heavy discharge, dark blood discharge.Most recent follow-up information incorporated above includes: on 4-jun-2018: reporters information updated.Added events short term memory loss, endometriosis, bladder problems: weak bladder , urinary problems :stress incontinence, sneezing, coughing, back pain, uti's : yeast infection ,bacterial infection, squamous cell carcinoma of the vulva, vaginal cancer, hidradenitis, trails of light.Events outcome and onset date were updated.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage :a piece of blank fishing line came out of my breast"), pelvic pain ("pain: pelvic pain"), genital haemorrhage ("abnormal bleeding (general)"), squamous cell carcinoma of the vulva ("tumor/treatoma/cancer type: squamous cell vulvar"), adenosquamous cell carcinoma ("tumor/teratoma/cancer type: squamous cell"), basedow's disease ("autoimmune disorder: graves") and vaginal cancer ("tumor/treatoma /cancer type: vaginal entrance") in a 41-year-old female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's past medical history included thyroid disorder, psychiatric disorder nos, graves' disease in 2002, rash, visual disturbance, mood swings and hot flushes.Concurrent conditions included body mass index normal, uterine tenderness, paratubal cyst, polycystic ovarian syndrome, hormonal imbalance, uterine bleeding, dysfunctional uterine bleeding and adhesion.Concomitant products included oral contraceptive nos for hormonal imbalance as well as bactrim (mortin), esomeprazole magnesium (nexium), hydroxyzine, levothyroxine sodium (synthroid), naproxen sodium (aleve), quetiapine and sertraline.On (b)(6) 2006, the patient had essure (ess205) inserted.In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and endometriosis ("endometriosis").In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid function test abnormal ("hormonal changes describe- thyroid"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping) sharp and pinching pain, long lasting periods with severe cramps"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight increased ("weight gain"), irritable bowel syndrome ("gastrointestinal and digestive system condition"), arthralgia ("joint pain"), sneezing ("sneezing") and fungal infection ("uti's : yeast infection").In 2008, the patient experienced migraine ("migraines"), headache ("headaches : severe throbbing headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), rash ("rashes or skin conditions: rash") and hidradenitis ("rashesh or skin condition :hidradenitis").In 2010, the patient experienced urinary incontinence ("bladder problems: week bladder"), stress urinary incontinence ("urinary problems :stress incontinence"), blood oestrogen abnormal ("hormonal changes describe: estrogen") and cough ("coughing").In 2015, the patient experienced adenosquamous cell carcinoma (seriousness criterion medically significant).On an unknown date, the patient experienced squamous cell carcinoma of the vulva (seriousness criterion medically significant), basedow's disease (seriousness criterion medically significant), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth fracture ("dental problems : teeth are crumbling"), vaginal discharge ("vaginal discharge"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), vitreous floaters ("eye problem :black dots in pheripheral vision"), post-traumatic stress disorder ("ptsd: post-traumatic stress disorder"), amnesia ("short term memory loss"), back pain ("excessive back pain"), bacterial infection ("uti's:bacterial infection"), photopsia ("vision problem /eye problem: trails of light") and vaginal cancer (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oopherectomy) and surgery (hysterectomy (full) with bilateral salpingo-oopherectomy).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, squamous cell carcinoma of the vulva, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, urinary incontinence, stress urinary incontinence, migraine, headache, blood disorder, cardiac disorder, nausea, tooth fracture, dysmenorrhoea, vaginal discharge, fatigue, irritable bowel syndrome, neuralgia, blood oestrogen abnormal, anxiety, post-traumatic stress disorder, amnesia, endometriosis, sneezing, cough, back pain, fungal infection, bacterial infection, hidradenitis, photopsia and vaginal cancer outcome was unknown and the dyspareunia, weight increased, alopecia, arthralgia, visual impairment and vitreous floaters had resolved.The reporter considered adenosquamous cell carcinoma, alopecia, amnesia, anxiety, arthralgia, back pain, bacterial infection, basedow's disease, blood disorder, blood oestrogen abnormal, calcium metabolism disorder, cardiac disorder, cough, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, fungal infection, genital haemorrhage, headache, hidradenitis, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pelvic pain, photopsia, post-traumatic stress disorder, rash, sneezing, squamous cell carcinoma of the vulva, stress urinary incontinence, thyroid function test abnormal, tooth fracture, urinary incontinence, vaginal cancer, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters and weight increased to be related to essure (ess205).The reporter commented: insertion details: device placed left with 5 coils trailing.Right 4 coils trailing.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Current weight 170 lbs.On (b)(6) 2010 pathology test revealed, endo· and ectocervix with squamous metaplasia, and acute and chronic cervicitis.Secretory endometrium.Secretory endometrium.Unremarkable myometrium.Para tubal cysts.Polycystic ovaries consistent with polycystic ovary syndrome.Oviducts contain an embedded metallic device (prior sterilization procedure).No malignancy identified.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: cramping with heavy discharge, dark blood discharge.Most recent follow-up information incorporated above includes: on 18-jun-2018: previously reported follow up receipt date 04-jun-2018 was incorrect, correct date was 05-jun-2018.On 5-jun-2018: reporter added.Patient¿s relevant history updated.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage :a piece of blank fishing line came out of my breast"), pelvic pain ("pain: pelvic pain"), genital haemorrhage ("abnormal bleeding (general)"), squamous cell carcinoma of the vulva ("tumor/treatoma/cancer type: squamous cell vulvar"), adenosquamous cell carcinoma ("tumor/teratoma/cancer type: squamous cell"), basedow's disease ("autoimmune disorder: graves"), urinary tract infection fungal ("uti's : yeast infection"), urinary tract infection bacterial ("uti's:bacterial infection") and vaginal cancer ("tumor/treatoma /cancer type: vaginal entrance") in a 41-year-old female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's past medical history included thyroid disorder, psychiatric disorder nos, graves' disease in 2002, rash, visual disturbance, mood swings and hot flushes.Concurrent conditions included body mass index normal, uterine tenderness, paratubal cyst, polycystic ovarian syndrome, hormonal imbalance, uterine bleeding, dysfunctional uterine bleeding and adhesion.Concomitant products included oral contraceptive nos for hormonal imbalance as well as bactrim (motrin), esomeprazole magnesium (nexium), hydroxyzine, levothyroxine sodium (synthroid), naproxen sodium (aleve), quetiapine and sertraline.In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and endometriosis ("endometriosis").On (b)(6) 2006, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), thyroid function test abnormal ("hormonal changes describe- thyroid"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping) sharp and pinching pain, long lasting periods with severe cramps"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), weight increased ("weight gain"), irritable bowel syndrome ("gastrointestinal and digestive system condition"), arthralgia ("joint pain"), sneezing ("sneezing") and urinary tract infection fungal (seriousness criterion medically significant).In 2008, the patient experienced migraine ("migraines"), headache ("headaches : severe throbbing headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), rash ("rashes or skin conditions: rash") and hidradenitis ("rashes or skin condition :hidradenitis").In 2010, the patient experienced urinary incontinence ("bladder problems: week bladder"), stress urinary incontinence ("urinary problems :stress incontinence"), blood oestrogen abnormal ("hormonal changes describe: estrogen") and cough ("coughing").In 2015, the patient experienced adenosquamous cell carcinoma (seriousness criterion medically significant).On an unknown date, the patient experienced squamous cell carcinoma of the vulva (seriousness criterion medically significant), basedow's disease (seriousness criterion medically significant), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth fracture ("dental problems : teeth are crumbling"), vaginal discharge ("vaginal discharge"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), vitreous floaters ("eye problem :black dots in peripheral vision"), post-traumatic stress disorder ("ptsd: post-traumatic stress disorder"), amnesia ("short term memory loss"), back pain ("excessive back pain"), urinary tract infection bacterial (seriousness criterion medically significant), photopsia ("vision problem /eye problem: trails of light") and vaginal cancer (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oopherectomy).Essure (ess205) was removed on (b)(6) 2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, squamous cell carcinoma of the vulva, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, urinary incontinence, stress urinary incontinence, migraine, headache, blood disorder, cardiac disorder, nausea, tooth fracture, dysmenorrhoea, vaginal discharge, fatigue, irritable bowel syndrome, neuralgia, blood oestrogen abnormal, anxiety, post-traumatic stress disorder, amnesia, endometriosis, sneezing, cough, back pain, urinary tract infection fungal, urinary tract infection bacterial, hidradenitis, photopsia and vaginal cancer outcome was unknown and the dyspareunia, weight increased, alopecia, arthralgia, visual impairment and vitreous floaters had resolved.The reporter considered adenosquamous cell carcinoma, alopecia, amnesia, anxiety, arthralgia, back pain, basedow's disease, blood disorder, blood oestrogen abnormal, calcium metabolism disorder, cardiac disorder, cough, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, headache, hidradenitis, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pelvic pain, photopsia, post-traumatic stress disorder, rash, sneezing, squamous cell carcinoma of the vulva, stress urinary incontinence, thyroid function test abnormal, tooth fracture, urinary incontinence, urinary tract infection bacterial, urinary tract infection fungal, vaginal cancer, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters and weight increased to be related to essure (ess205).The reporter commented: insertion details: device placed left with 5 coils trailing.Right 4 coils trailing.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Current weight 170 lbs.On (b)(6) 2010 pathology test revealed, endo· and ectocervix with squamous metaplasia, and acute and chronic cervicitis.Secretory endometrium.Secretory endometrium.Unremarkable myometrium.Para tubal cysts.Polycystic ovaries consistent with polycystic ovary syndrome.Oviducts contain an embedded metallic device (prior sterilization procedure).No malignancy identified.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: cramping with heavy discharge, dark blood discharge.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage :a piece of blank fishing line came out of my breast'), pelvic pain ('pain: pelvic pain'), genital haemorrhage ('abnormal bleeding (general)'), squamous cell carcinoma of the vulva ('tumor/treatoma/cancer type: squamous cell vulvar'), adenosquamous cell carcinoma ('tumor/teratoma/cancer type: squamous cell'), basedow's disease ('autoimmune disorder: graves'), urinary tract infection fungal ('uti's : yeast infection'), urinary tract infection bacterial ('uti's:bacterial infection') and vaginal cancer ('tumor/treatoma /cancer type: vaginal entranance') in a 41-year-old female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's medical history included graves' disease in 2002, rash, visual disturbance, mood swings and hot flushes.Concurrent conditions included thyroid disorder, psychiatric disorder nos, body mass index normal, uterine tenderness, paratubal cyst, polycystic ovarian syndrome, hormonal imbalance, uterine bleeding, dysfunctional uterine bleeding and adhesion.Concomitant products included oral contraceptive nos for hormonal imbalance as well as esomeprazole, hydroxyzine, levothyroxine sodium (synthroid), naproxen sodium (aleve), quetiapine, sertraline and sulfamethoxazole;trimethoprim (mortin).In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and endometriosis ("endometriosis").On (b)(6) 2006, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping) sharp and pinching pain, long lasting periods with severe cramps"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), irritable bowel syndrome ("gastrointestinal and digestive system condition"), arthralgia ("joint pain"), sneezing ("sneezing") and urinary tract infection fungal (seriousness criterion medically significant) and was found to have thyroid function test abnormal ("hormonal changes describe- thyroid") and weight increased ("weight gain").In 2008, the patient experienced migraine ("migraines"), headache ("headaches : severe throbbing headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), rash ("rashes or skin conditions: rash") and hidradenitis ("rashesh or skin condition :hidradenitis").In 2010, the patient experienced urinary incontinence ("bladder problems: week bladder"), stress urinary incontinence ("urinary problems :stress incontinence") and cough ("coughing") and was found to have blood oestrogen abnormal ("hormonal changes describe: estrogen").In 2015, the patient was found to have adenosquamous cell carcinoma (seriousness criterion medically significant).On an unknown date, the patient was found to have squamous cell carcinoma of the vulva (seriousness criterion medically significant) and vaginal cancer (seriousness criterion medically significant) and experienced basedow's disease (seriousness criterion medically significant), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth fracture ("dental problems : teeth are crumbling"), vaginal discharge ("vaginal discharge"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), vitreous floaters ("eye problem :black dots in pheripheral vision"), post-traumatic stress disorder ("ptsd: post-traumatic stress disorder"), amnesia ("short term memory loss"), back pain ("excessive back pain"), urinary tract infection bacterial (seriousness criterion medically significant), photopsia ("vision problem /eye problem: trails of light"), pain ("my body hurt everywhere"), vomiting ("could not hold food down") and asthenia ("could not hold food down").The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oopherectomy).Essure (ess205) was removed on 1-mar-2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, squamous cell carcinoma of the vulva, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, urinary incontinence, stress urinary incontinence, migraine, headache, blood disorder, cardiac disorder, nausea, tooth fracture, dysmenorrhoea, vaginal discharge, fatigue, irritable bowel syndrome, neuralgia, blood oestrogen abnormal, anxiety, post-traumatic stress disorder, amnesia, endometriosis, sneezing, cough, back pain, urinary tract infection fungal, urinary tract infection bacterial, hidradenitis, photopsia, vaginal cancer, pain, vomiting and asthenia outcome was unknown and the dyspareunia, weight increased, alopecia, arthralgia, visual impairment and vitreous floaters had resolved.The reporter considered adenosquamous cell carcinoma, alopecia, amnesia, anxiety, arthralgia, asthenia, back pain, basedow's disease, blood disorder, blood oestrogen abnormal, calcium metabolism disorder, cardiac disorder, cough, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, headache, hidradenitis, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pain, pelvic pain, photopsia, post-traumatic stress disorder, rash, sneezing, squamous cell carcinoma of the vulva, stress urinary incontinence, thyroid function test abnormal, tooth fracture, urinary incontinence, urinary tract infection bacterial, urinary tract infection fungal, vaginal cancer, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters, vomiting and weight increased to be related to essure (ess205).The reporter commented: insertion details: device placed left with 5 coils trailing.Right 4 coils trailing.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Current weight 170 lbs.On (b)(6) 2010 pathology test revealed, endo· and ectocervix with squamous metaplasia, and acute and chronic cervicitis.Secretory endometrium.Secretory endometrium.Unremarkable myometrium.Para tubal cysts.Polycystic ovaries consistent with polycystic ovary syndrome.Oviducts contain an embedded metallic device (prior sterilization procedure).No malignancy identified.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: cramping with heavy discharge, dark blood discharge.Concerning the injuries reported in this case, the following ones were described in patient¿s social media records: allergy to antibiotics, generalized body pain, vomiting, hidradenitis, weight gain, squamous cell carcinoma and weakness.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-oct-2019: information received via social media.Following events ¿my body hurt everywhere, could not hold food down and i got weak¿ were added.On 2-oct-2019: plaintiff fact sheet received.No new information.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 spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage :a piece of blank fishing line came out of my breast') and pelvic pain ('pain: pelvic pain') in a 41-year-old female patient who had essure (ess205) (batch no.620749) 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 "she did not undergo essure confirmation test".The patient's medical history included graves' disease in 2002, rash, visual disturbance, mood swings and hot flushes.Current weight 170 lbs.On (b)(6)2010 pathology test revealed, endo· and ectocervix with squamous metaplasia, and acute and chronic cervicitis.Secretory endometrium.Secretory endometrium.Unremarkable myometrium.Para tubal cysts.Polycystic ovaries consistent with polycystic ovary syndrome.Oviducts contain an embedded metallic device (prior sterilization procedure).No malignancy identified.Concurrent conditions included thyroid disorder, psychiatric disorder nos, body mass index normal, uterine tenderness, paratubal cyst, polycystic ovarian syndrome, hormonal imbalance, uterine bleeding, dysfunctional uterine bleeding and adhesion.Concomitant products included oral contraceptive nos for hormonal imbalance as well as esomeprazole, hydroxyzine, levothyroxine sodium (synthroid), naproxen sodium (aleve), quetiapine, sertraline and sulfamethoxazole;trimethoprim (mortin).In 2006, the patient experienced device breakage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and endometriosis ("endometriosis").On (b)(6)2006, the patient had essure (ess205) inserted.In 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping) sharp and pinching pain, long lasting periods with severe cramps"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), irritable bowel syndrome ("gastrointestinal and digestive system condition"), arthralgia ("joint pain"), sneezing ("sneezing") and urinary tract infection fungal ("uti's : yeast infection") and was found to have thyroid function test abnormal ("hormonal changes describe- thyroid") and weight increased ("weight gain").In 2008, the patient experienced migraine ("migraines"), headache ("headaches : severe throbbing headaches") and alopecia ("hair loss").In 2009, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), rash ("rashes or skin conditions: rash") and hidradenitis ("rashesh or skin condition :hidradenitis").In 2010, the patient experienced urinary incontinence ("bladder problems: week bladder"), stress urinary incontinence ("urinary problems :stress incontinence") and cough ("coughing") and was found to have blood oestrogen abnormal ("hormonal changes describe: estrogen").In 2015, the patient was found to have adenosquamous cell carcinoma ("tumor/teratoma/cancer type: squamous cell").On an unknown date, the patient was found to have squamous cell carcinoma of the vulva ("tumor/treatoma/cancer type: squamous cell vulvar") and vaginal cancer ("tumor/treatoma /cancer type: vaginal entranance") and experienced basedow's disease ("autoimmune disorder: graves"), depression ("depression"), blood disorder ("blood or heart disorder/condition type: unspecified"), cardiac disorder ("blood or heart disorder/condition type: unspecified"), tooth fracture ("dental problems : teeth are crumbling"), vaginal discharge ("vaginal discharge"), neuralgia ("nerve pain"), drug hypersensitivity ("allergies to antibiotics/medicinal allergy"), anxiety ("anxiety"), calcium metabolism disorder ("calcium"), visual impairment ("vision eye problem"), vitreous floaters ("eye problem :black dots in pheripheral vision"), post-traumatic stress disorder ("ptsd: post-traumatic stress disorder"), amnesia ("short term memory loss"), back pain ("excessive back pain"), urinary tract infection bacterial ("uti's:bacterial infection"), photopsia ("vision problem /eye problem: trails of light"), pain ("my body hurt everywhere"), vomiting ("could not hold food down"), haematochezia ("bloody when i go potty"), abdominal distension ("swelling in the upper abdomen with pain"), renal pain ("kidneys are killing me"), bone pain ("the large piece of bone was preventing the healing and causing the pain"), pyrexia ("fever") and abdominal pain upper ("upper abdomen with pain").The patient was treated with surgery (hysterectomy (full) with bilateral salpingo-oophorectomy).Essure (ess205) was removed on (b)(6)2010.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, squamous cell carcinoma of the vulva, thyroid function test abnormal, basedow's disease, vaginal haemorrhage, menorrhagia, female sexual dysfunction, depression, rash, urinary incontinence, stress urinary incontinence, migraine, headache, blood disorder, cardiac disorder, nausea, tooth fracture, dysmenorrhoea, vaginal discharge, fatigue, irritable bowel syndrome, neuralgia, blood oestrogen abnormal, anxiety, post-traumatic stress disorder, amnesia, endometriosis, sneezing, cough, back pain, urinary tract infection fungal, urinary tract infection bacterial, hidradenitis, photopsia, vaginal cancer, pain, vomiting, haematochezia, abdominal distension, renal pain, bone pain and abdominal pain upper outcome was unknown, the dyspareunia, weight increased, alopecia, arthralgia, visual impairment and vitreous floaters had resolved and the pyrexia had not resolved.The reporter considered abdominal distension, abdominal pain upper, adenosquamous cell carcinoma, alopecia, amnesia, anxiety, arthralgia, back pain, basedow's disease, blood disorder, blood oestrogen abnormal, bone pain, calcium metabolism disorder, cardiac disorder, cough, depression, device breakage, drug hypersensitivity, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, haematochezia, headache, hidradenitis, irritable bowel syndrome, menorrhagia, migraine, nausea, neuralgia, pain, pelvic pain, photopsia, post-traumatic stress disorder, pyrexia, rash, renal pain, sneezing, squamous cell carcinoma of the vulva, stress urinary incontinence, thyroid function test abnormal, tooth fracture, urinary incontinence, urinary tract infection bacterial, urinary tract infection fungal, vaginal cancer, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters, vomiting and weight increased to be related to essure (ess205).The reporter commented: insertion details: device placed left with 5 coils trailing.Right 4 coils trailing.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.4 kg/sqm.Pathology test - on (b)(6)2010: results: endo· and ectocervix with squamous metaplasia.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: cramping with heavy discharge, dark blood discharge.Concerning the injuries reported in this case, the following ones were described in patient¿s social media records: allergy to antibiotics, generalized body pain, vomiting, hidradenitis, weight gain, squamous cell carcinoma and weakness, haematochezia, abdominal distension, kidney pain, bone pain, pyrexia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jan-2020: social media received: reporters were added.New events- haematochezia, abdominal distension, kidney pain, bone pain, pyrexia, were added.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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