| Model Number ESS205 |
| Device Problems
Break (1069); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Urticaria (2278); Anxiety (2328); Arthralgia (2355); Depression (2361); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 12/01/2005 |
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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'), device dislocation ('migration of essure device location of device: hip') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: current weight (b)(6).Previously administered products included for an unreported indication: depo provera, mirena and oral contraceptive.Concomitant products included ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia) "), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In (b)(6) 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema") and eczema ("rashes or skin conditions type: acne, hives, eczema").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe:painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy") and menstrual disorder ("huge clots during my menstrual cycle").The patient was treated with antibiotics, cortisone, dicycloverin hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote) and paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, menorrhagia, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder and insomnia outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results:the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-jul-2019: pfs received: case became valid and incident.Injury nos was replaced with new events- mood swings, brain fog, menorrhagia, vaginal bleeding, i have developed an allergy to bee stings, uti, yeast infection, anxiety, depression, acne, hives, eczema, migration of essure device location of device: hip, dental problems, device breakage, nickel allergy, dysmenorrhea, dyspareunia, vaginal discharge, i have floaters, double vision and tunnel vision, weight gain, metallic taste in mouth, pelvic pain, abdominal pain, back pain, joint pain, nose bleeds, insomnia, painful right knee swelling, weight decreased.Reporter information, patients dob, demographics, events onset date, treatment drugs, lab data and concomitant drugs were added.Incident: no lot number 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), device dislocation ('migration of essure device location of device: hip') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: current weight 175 lbs.Previously administered products included for an unreported indication: depo provera, mirena and oral contraceptive.Concomitant products included ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia) "), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In february 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema") and eczema ("rashes or skin conditions type: acne, hives, eczema").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe:painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy") and menstrual disorder ("huge clots during my menstrual cycle").The patient was treated with antibiotics, cortisone, dicycloverin hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote) and paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, menorrhagia, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder and insomnia outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results:the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: significant case correction, ppc added.No new follow-up information was received from the reporter.Incident: no lot number 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), device dislocation ('migration of essure device location of device: hip') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: current weight 175 lbs.Previously administered products included for an unreported indication: depo provera, mirena and oral contraceptive.Concomitant products included ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia) "), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In (b)(6) 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema") and eczema ("rashes or skin conditions type: acne, hives, eczema").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe:painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy") and menstrual disorder ("huge clots during my menstrual cycle").The patient was treated with antibiotics, cortisone, dicycloverine hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote) and paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, menorrhagia, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder and insomnia outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results:the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-jul-2019: quality safety evaluation of ptc.Incident: 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage'), device dislocation ('migration of essure device location of device: hip'), menorrhagia ('abnormal bleeding (vaginal, menorrhagia)') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy (dates of live births: (b)(6) 2004, (b)(6) 2005).Current weight 175 lbs.Previously administered products included for an unreported indication: mirena in 2005, depo provera and oral contraceptive.Concurrent conditions included morbid obesity.Concomitant products included diphenhydramine hydrochloride since 2014, ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In (b)(6) 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema"), eczema ("rashes or skin conditions type: acne, hives, eczema") and rash ("rash").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe: painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy") and menstrual disorder ("huge clots during my menstrual cycle").The patient was treated with antibiotics, cortisone, dicycloverin hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets) and surgery (anticipated/scheduled date: before (b)(6) of 2019 and dilation and curettage).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, menorrhagia, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder, insomnia and rash outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, rash, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.8 kg/sqm.Hysterosalpingogram - on an unknown date: results: the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way; in (b)(6) 2005: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-oct-2019: pfs received.New event rash was added.Reporter information, medical history, concomitant drug and lab data were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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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'), device dislocation ('migration of essure device location of device: hip'), menorrhagia ('abnormal bleeding (vaginal, menorrhagia)') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy (dates of live births: (b)(6) 2004, (b)(6) 2005), tunnel vision and urinary tract infection.Current weight 175 lbs.Previously administered products included for an unreported indication: mirena in 2005, depo provera and oral contraceptive.Concurrent conditions included obesity.Concomitant products included diphenhydramine hydrochloride since 2014, ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In (b)(6) 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema"), eczema ("rashes or skin conditions type: acne, hives, eczema") and rash ("rash").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe:painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy"), menstrual disorder ("huge clots during my menstrual cycle") and genital haemorrhage ("abnormal bleeding (general)").The patient was treated with antibiotics, cortisone, dicycloverine hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets) and surgery (anticipated/scheduled date: before (b)(6) 2019 and dilation and curettage).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, menorrhagia, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder, insomnia, rash and genital haemorrhage outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, genital haemorrhage, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, rash, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).The reporter commented: discrepancy noted : the plaintiff states that she has not had essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.8 kg/sqm.Hysterosalpingogram - on an unknown date: results:the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way; in (b)(6) 2005: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-feb-2020: plaintiff fact sheet received : event added- abnormal bleeding (general).Medical history added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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'), device dislocation ('migration of essure device location of device: hip'), perforation ('one of coil was perforated'), menorrhagia ('abnormal bleeding (vaginal, menorrhagia)') and tunnel vision ('vision/eye problems type: i have floaters, double vision and tunnel vision') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy (dates of live births: (b)(6) 2004, (b)(6) 2005), tunnel vision and urinary tract infection.Current weight 175 lbs.Previously administered products included for an unreported indication: mirena in 2005, depo provera and oral contraceptive.Concurrent conditions included obesity.Concomitant products included diphenhydramine hydrochloride since 2014, ibuprofen (excedrin ib) since 2003 and levonorgestrel (mirena) in 2005.On (b)(6) 2005, the patient had essure (ess205) inserted.In (b)(6) 2005, the patient experienced pelvic pain ("pain/pelvic pain/constant pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)") and vaginal discharge ("vaginal discharge").In (b)(6) 2005, the patient experienced insomnia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In (b)(6) 2005, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), arthralgia ("pain/joint aches and pain/ hip pain") and back pain ("pain/back pain").In (b)(6) 2006, the patient experienced mood swings ("hormonal changes describe: mood swings, brain fog"), depression ("psychological or psychiatric problems condition: anxiety and depression") and anxiety ("psychological or psychiatric problems condition: anxiety and depression").In (b)(6) 2006, the patient experienced abdominal pain ("pain/abdominal pain").In (b)(6) 2007, the patient experienced urticaria ("rashes or skin conditions type: acne, hives, eczema"), acne ("rashes or skin conditions type: acne, hives, eczema"), eczema ("rashes or skin conditions type: acne, hives, eczema") and rash ("rash").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one: weight gain").In (b)(6) 2013, the patient experienced joint swelling ("other injuries) or complication (s) please describe:painful swelling of right knee").In 2014, the patient experienced epistaxis ("abnormal bleeding (general) nose bleeds").In (b)(6) 2015, the patient experienced vulvovaginal mycotic infection ("infection (other) describe: yeast").In (b)(6) 2015, the patient experienced dysgeusia ("other injuries) or complication (s) please describe: metallic taste in mouth, painful swelling of right knee, insomnia, hip pain").In 2015, the patient experienced tunnel vision (seriousness criterion medically significant), vitreous floaters ("vision/eye problems type: i have floaters, double vision and tunnel vision") and diplopia ("vision/eye problems type: i have floaters, double vision and tunnel vision").In (b)(6) 2016, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2017, the patient was found to have weight decreased ("weight gain / loss specify which one: weight loss").In (b)(6) 2017, the patient experienced tooth disorder ("dental problems").In (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant).On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), perforation (seriousness criterion medically significant), feeling abnormal ("hormonal changes describe: mood swings, brain fog"), allergy to arthropod sting ("i have developed an allergy to bee stings"), allergy to metals ("nickel allergy"), menstrual disorder ("huge clots during my menstrual cycle"), genital haemorrhage ("abnormal bleeding (general)") and fibromyalgia ("fibromyalgia").The patient was treated with antibiotics, cortisone, dicycloverine hydrochloride (bentyl), epinephrine, fluconazole (diflucan), hydrocortisone, naproxen, tramadol, valproate semisodium (depakote), paracetamol + caffeine + pyrilamine maleate (midol complete formula caplets) and surgery (anticipated/scheduled date: before (b)(6) 2019 and dilation and curettage).Essure (ess205) treatment was not changed.At the time of the report, the device breakage, device dislocation, perforation, menorrhagia, tunnel vision, epistaxis, pelvic pain, vaginal haemorrhage, feeling abnormal, mood swings, allergy to arthropod sting, urinary tract infection, vulvovaginal mycotic infection, depression, anxiety, urticaria, acne, eczema, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, vitreous floaters, diplopia, weight decreased, dysgeusia, arthralgia, abdominal pain, back pain, weight increased, joint swelling, menstrual disorder, insomnia, rash, genital haemorrhage and fibromyalgia outcome was unknown.The reporter considered abdominal pain, acne, allergy to arthropod sting, allergy to metals, anxiety, arthralgia, back pain, depression, device breakage, device dislocation, diplopia, dysgeusia, dysmenorrhoea, dyspareunia, eczema, epistaxis, feeling abnormal, fibromyalgia, genital haemorrhage, insomnia, joint swelling, menorrhagia, menstrual disorder, mood swings, pelvic pain, perforation, rash, tooth disorder, tunnel vision, urinary tract infection, urticaria, vaginal discharge, vaginal haemorrhage, vitreous floaters, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).The reporter commented: discrepancy noted : the plaintiff states that she has not had essure removed.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.8 kg/sqm.Hysterosalpingogram - on an unknown date: results:the doctor said everything looked like it was in place.He then showed me a picture from the test and sent me on my way; in (b)(6) 2005: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: social media received events " one of coils was perforated, fibromyalgia" were added.Reporter information was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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