| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Expulsion (2933); Appropriate Term/Code Not Available (3191); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Perforation (2001); Abnormal Vaginal Discharge (2123); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687)
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| Event Date 01/01/2013 |
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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 abdominal pain ("abdominal pain") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping/lower abdominal pain"), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), depression ("depression"), anxiety ("anxiety"), weight decreased ("severe weightless"), abdominal pain upper ("upper abdominal pain"), fatigue ("fatigue"), diarrhoea ("diarrhea"), dysmenorrhoea ("severe menstrual cramps"), dyspareunia ("painful intercourse"), menstrual disorder ("menstrual flow"), vaginal discharge ("vaginal discharge") and rectal haemorrhage ("rectal bleeding").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the abdominal pain, abdominal pain lower, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, dyspareunia, menstrual disorder, vaginal discharge and rectal haemorrhage outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, anxiety, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, hypoaesthesia, menstrual disorder, paraesthesia, rectal haemorrhage, vaginal discharge, vaginal infection and weight decreased to be related to essure.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptoms.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 the essure device"), perforation ("perforation of the essure device"), abdominal pain ("abdominal pain") and genital haemorrhage ("heavy and irregula bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In 2013, 118 days before insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("cramping/lower abdominal pain/sever cramping"), back pain ("back pain") and weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), depression ("depression"), anxiety ("anxiety"), weight decreased ("severe weightless"), abdominal pain upper ("upper abdominal pain"), fatigue ("fatigue"), diarrhoea ("diarrhea"), dysmenorrhoea ("severe menstral cramps"), dyspareunia ("painful intercourse"), menstrual disorder ("menstrual flow"), vaginal discharge ("vaginal discharge") and rectal haemorrhage ("rectal bleeding").The patient was treated with surgery (on (b)(6) 2016, patient had underwent a pelvic surgery) and surgery (hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, perforation, abdominal pain, genital haemorrhage, abdominal pain lower, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, dyspareunia, menstrual disorder, vaginal discharge, rectal haemorrhage, back pain and weight increased outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, anxiety, back pain, depression, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, hypoaesthesia, menstrual disorder, paraesthesia, perforation, rectal haemorrhage, vaginal discharge, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptons.Most recent follow-up information incorporated above includes: on 15-sep-2017: new reporter, lab test and events sever cramping, abdominal pain, pelvic pain, heavy and irregular bleeding weight gain ,migration /perforation of the essure device and back pain added.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 the essure device"), perforation ("perforation of the essure device"), uterine haemorrhage ("abnormal uterine bleeding"), abdominal pain ("abdominal pain") and genital haemorrhage ("heavy and irregular bleeding") in an adult female patient who had essure (batch no.B34602) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included hypoglycemia.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, vaginal infection and vaginal bleeding.Concomitant products included cyclobenzaprine, dicycloverin hydrochloride (bentyl), doxycycline, ibuprofen, meloxicam, methylprednisolone acetate (depo-medrol) and trazodone.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and weight increased ("weight gain").In october 2013, the patient experienced dysmenorrhoea ("severe menstrual cramps") and allergy to metals ("nickel allergy").In november 2013, the patient experienced fatigue ("fatigue").In december 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In january 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia"), vaginal haemorrhage ("vaginal bleeding") and emotional disorder ("emotional outbursts").In february 2014, the patient experienced dyspareunia ("painful intercourse") and nausea ("nausea").In march 2014, the patient experienced vaginal discharge ("vaginal discharge").In june 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping"), back pain ("back pain") and genital pain ("genital pain").In july 2014, the patient experienced diarrhoea ("diarrhea") and rectal haemorrhage ("severe rectal bleeding").In april 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), weight decreased ("severe weightless"), abdominal pain upper ("upper abdominal pain") and mood swings ("mood swings").The patient was treated with surgery (patient had underwent a pelvic surgery) and surgery (hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, perforation, uterine haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, rectal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals and emotional disorder outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, depression, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about january 2016, plaintiff sought medical attention for her symptoms.Diagnostic results: positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs and medical record received.Medically confirmed case.Reporter and patient demographics were added.Concomitant disease ,concomitant drugs were added.Updated suspect drug indication.Events vaginal bleeding, menorrhagia, apareunia, severe rectal bleeding, mood swings, migraines, headaches, nausea, nickel allergy, seizures, emotional outbursts, genital pain and abnormal uterine bleeding added pfs.On (b)(6) 2018: medical record received.Reporter added.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 expulsion ("migration of essure device location of device: endometrial canal"), perforation ("perforation of the essure device"), uterine haemorrhage ("abnormal uterine bleeding"), abdominal pain ("abdominal pain") and genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)") in an adult female patient who had essure (batch no.B34602, 834802) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included hypoglycemia and c-section.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea and vomiting.Concomitant products included cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol) and trazodone.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and weight increased ("weight gain").In (b)(6) 2013, the patient experienced dysmenorrhoea ("severe menstrual cramps, dysmenorrhea (cramping)") and allergy to metals ("nickel allergy").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia"), vaginal haemorrhage ("vaginal bleeding") and emotional disorder ("emotional outbursts").In february 2014, the patient experienced dyspareunia ("painful intercourse") and nausea ("nausea").In (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping"), back pain ("back pain") and genital pain ("genital pain").In (b)(6) 2014, the patient experienced diarrhoea ("diarrhea") and rectal haemorrhage ("severe rectal bleeding").In april 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), weight decreased ("severe weightless"), abdominal pain upper ("upper abdominal pain") and mood swings ("mood swings").The patient was treated with surgery (underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy), surgery (hysterectomy (full), bilateral salpingectomy), and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, rectal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals and emotional disorder outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on an unknown date: an intrauterine device in the endometrial canal.Positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain.Most recent follow-up information incorporated above includes: on 12-apr-2018: pfs and mr received: new lot no, concomitant disease and medication, event device dislocation updated to device expulsion.Intervention marked for the event uterine haemorrhage.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 expulsion ("migration of essure device location of device: endometrial canal"), perforation ("perforation of the essure device"), uterine haemorrhage ("abnormal uterine bleeding"), abdominal pain ("abdominal pain"), genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)" and rectal haemorrhage ("severe rectal bleeding") in an adult female patient who had essure (batch no: b34602, 834802-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included hypoglycemia and c-section.X-ray: on (b)(6) 2013.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea, vomiting, intervertebral disc protrusion, sciatica, arthritis, fainting, pinched nerve, neck injury and overweight.Concomitant products included cefixime (flexeril), ciprofloxacin, cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, fluoxetine hydrochloride (prozac), hydrocodone bitartrate;paracetamol (hydrocodone/acetaminophen), hydrocodone bitartrate;paracetamol (norco), ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol), ondansetron and trazodone.In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required) and genital haemorrhage (seriousness criterion medically significant) and was found to have weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dysmenorrhoea ("severe "menstrual" cramps, dysmenorrhea (cramping)", vaginal discharge ("vaginal discharge") and allergy to metals ("nickel allergy").On (b)(6) 2013, the patient experienced fatigue ("fatigue").On (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").On (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia/abnormally severe bleeding during menstrual cycle/increased time period of bleeding during cycle"), vaginal haemorrhage ("vaginal bleeding") and emotional disorder ("emotional outbursts").On (b)(6) 2014, the patient experienced dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)") and nausea ("nausea").In 2014, the patient experienced dental caries ("dental problems/tooth decay").On (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping/lower stomach pain"), back pain ("back pain/pain in my lower back") and genital pain ("genital pain/genital area pain").On (b)(6) 2014, the patient experienced rectal haemorrhage (seriousness criterion medically significant) and diarrhoea ("diarrhea").On (b)(6) 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), abdominal pain upper ("upper abdominal pain") and mood swings ("mood swings") and was found to have weight decreased ("severe weightless/ extreme weight loss").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy, hysterectomy with bilateral salpingectomy, total laparoscopic hysterectomy with bilateral salpingectomy and underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy) and had seven teeth pulled, plans to pull another ten teeth.Essure was removed on (b)(6) 2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, rectal haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals, emotional disorder and dental caries outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, dental caries, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about on (b)(6) 2016, plaintiff sought medical attention for her "symptoms".Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.8 kg/sqm.Ultrasound scan: on an unknown date: results: an intrauterine device in the endometrial canal.Positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-apr-2019: pfs received.Reporter information were updated.Medical history and concomitant drug were added.Event verbatim were updated as painful intercourse/ dyspareunia (painful sexual intercourse), back pain/pain in my lower back¸ pelvic pain/pain, cramping/lower abdominal pain/sever cramping/lower stomach pain, genital pain/genital area pain, severe weightless/ extreme weight loss, menstrual flow/ menorrhagia/abnormally severe bleeding during menstrual cycle/increased time period of bleeding during cycle.Event : dental problems/tooth decay were added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device expulsion ("migration of essure device location of device: endometrial canal"), perforation ("perforation of the essure device"), uterine haemorrhage ("abnormal uterine bleeding"), abdominal pain ("abdominal pain") and genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)") in an adult female patient who had essure (batch no.B34602) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included hypoglycemia and c-section.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea, vomiting, intervertebral disc protrusion, sciatica and arthritis.Concomitant products included cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, fluoxetine hydrochloride (prozac), ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol), trazodone and vicodin (norco).In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("severe menstrual cramps, dysmenorrhea (cramping)") and allergy to metals ("nickel allergy").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia"), vaginal haemorrhage ("vaginal bleeding") and emotional disorder ("emotional outbursts").In (b)(6) 2014, the patient experienced dyspareunia ("painful intercourse") and nausea ("nausea").In (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping"), back pain ("back pain") and genital pain ("genital pain").In (b)(6) 2014, the patient experienced diarrhoea ("diarrhea") and rectal haemorrhage ("severe rectal bleeding").In (b)(6) 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), weight decreased ("severe weightless"), abdominal pain upper ("upper abdominal pain") and mood swings ("mood swings").The patient was treated with surgery (underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy), surgery (hysterectomy (full), bilateral salpingectomy), surgery (total laparoscopic hysterectomy with bilateral salpingectomy) and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, rectal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals and emotional disorder outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan - on an unknown date: an intrauterine device in the endometrial canal.Positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-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 expulsion ('migration of essure device location of device: endometrial canal'), perforation ('perforation of the essure device'), uterine haemorrhage ('abnormal uterine bleeding') and abdominal pain ('abdominal pain') in an adult female patient who had essure (batch no.B34602,834802-inv,a33564) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included hypoglycemia, c-section, multigravida and multiparous.X-ray : (b)(6) 2013 positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea, vomiting, intervertebral disc protrusion, sciatica, arthritis, fainting, pinched nerve, neck injury and overweight.Concomitant products included cefixime (flexeril), ciprofloxacin, cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, fluoxetine hydrochloride (prozac), hydrocodone bitartrate;paracetamol (hydrocodone/acetaminophen), hydrocodone bitartrate;paracetamol (norco), ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol), ondansetron and trazodone.In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)") and was found to have weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("severe menstral cramps, dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and allergy to metals ("nickel allergy").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia/abnormally severe bleeding during menstrual cycle/increased time period of bleeding during cycle"), vaginal haemorrhage ("vaginal bleeding"), mood swings ("mood swings/hormonal changes: mood swings") and emotional disorder ("emotional outbursts/ hormonal changes: emotional outbursts").In (b)(6) 2014, the patient experienced dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)") and nausea ("nausea").In (b)(6) 2014, the patient was found to have weight decreased ("severe weightless/ extreme weight loss").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping/lower stomach pain"), back pain ("back pain/pain in my lower back") and genital pain ("genital pain/genital area pain").In 2014, the patient experienced dental caries ("dental problems/tooth decay").In (b)(6) 2014, the patient experienced rectal haemorrhage ("severe rectal bleeding") and diarrhoea ("diarrhea").In (b)(6) 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria hospitalization, medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy, hysterectomy with bilateral salpingectomy, total laparoscopic hysterectomy with bilateral salpingectomy and underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy) and had seven teeth pulled, plans to pull another ten teeth.Essure was removed on 18-may-2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, rectal haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals, emotional disorder and dental caries outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, dental caries, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: on or about (b)(6) -2016, plaintiff sought medical attention for her symptons.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.8 kg/sqm.Imaging procedure - on (b)(6) 2013: essure coils were in place.Pathology test - on (b)(6) 2013: surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Ultrasound scan - on (b)(6) 2013: results: an intrauterine device in the endometrial canal.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jun-2020: plaintiff fact sheet received.Reporter information updated.Lot number newly added.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 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('migration of essure device location of device: endometrial canal'), perforation ('perforation of the essure device'), uterine haemorrhage ('abnormal uterine bleeding') and abdominal pain ('abdominal pain') in an adult female patient who had essure (batch no.B34602,834802-inv,a33564) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included hypoglycemia, c-section, multigravida and multiparous.X-ray : (b)(6) 2013 positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea, vomiting, intervertebral disc protrusion, sciatica, arthritis, fainting, pinched nerve, neck injury and overweight.Concomitant products included cefixime (flexeril), ciprofloxacin, cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, fluoxetine hydrochloride (prozac), hydrocodone bitartrate;paracetamol (hydrocodone/acetaminophen), hydrocodone bitartrate;paracetamol (norco), ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol), ondansetron and trazodone.In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)") and was found to have weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("severe menstral cramps, dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and allergy to metals ("nickel allergy").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia/abnormally severe bleeding during menstrual cycle/increased time period of bleeding during cycle"), vaginal haemorrhage ("vaginal bleeding"), mood swings ("mood swings/hormonal changes: mood swings") and emotional disorder ("emotional outbursts/ hormonal changes: emotional outbursts").In (b)(6) 2014, the patient experienced dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)") and nausea ("nausea").In (b)(6) 2014, the patient was found to have weight decreased ("severe weightless/ extreme weight loss").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping/lower stomach pain"), back pain ("back pain/pain in my lower back") and genital pain ("genital pain/genital area pain").In 2014, the patient experienced dental caries ("dental problems/tooth decay").In (b)(6) 2014, the patient experienced rectal haemorrhage ("severe rectal bleeding") and diarrhoea ("diarrhea").In (b)(6) 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria hospitalization, medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy, hysterectomy with bilateral salpingectomy, total laparoscopic hysterectomy with bilateral salpingectomy and underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy) and had seven teeth pulled, plans to pull another ten teeth.Essure was removed on (b)(6) 2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, rectal haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals, emotional disorder and dental caries outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, dental caries, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptons.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.8 kg/sqm.Imaging procedure - on (b)(6) 2013: essure coils were in place.Pathology test - on (b)(6) 2013: surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Ultrasound scan - on (b)(6) 2013: results: an intrauterine device in the endometrial canal.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain.Lot number ( 834802 ) is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jul-2020: update of information (batch is invalid).We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('migration of essure device location of device: endometrial canal'), perforation ('perforation of the essure device'), uterine haemorrhage ('abnormal uterine bleeding') and abdominal pain ('abdominal pain') in an adult female patient who had essure (batch no.B34602,834802-inv,a33564) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included hypoglycemia, c-section, multigravida and multiparous.X-ray : (b)(6) 2013 positive home pregnancy test, although ours was negative, we must still consider that she may be pregnant.Because of this and the scant evidence for uti, she does not want any abdominal films or ct.She does not want to take any pain pills except tylenol nor does she want to take any antibiotics for uti until we have a positive culture result.Pregnancy testing-having rib pain.Also thinks she may be pregnant because of some light pink spotting, however it could be spotting from her essure implant.Took pregnancy test yesterday and it was negative.Concurrent conditions included constipation, hypokalemia, colitis, chest pain, hematuria, enteritis, costochondritis, discomfort, trichomonal vaginitis, vaginal bleeding, uterine bleeding, nausea, vomiting, intervertebral disc protrusion, sciatica, arthritis, fainting, pinched nerve, neck injury and overweight.Concomitant products included cefixime (flexeril), ciprofloxacin, cyclobenzaprine, dicycloverine hydrochloride (bentyl), doxycycline, fluoxetine hydrochloride (prozac), hydrocodone bitartrate;paracetamol (hydrocodone/acetaminophen), hydrocodone bitartrate;paracetamol (norco), ibuprofen, intrauterine contraceptive device (iud nos), meloxicam, methylprednisolone acetate (depo-medrol), ondansetron and trazodone.In 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain, perforation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("heavy and irregular bleeding, abnormal bleeding (general)") and was found to have weight increased ("weight gain").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced dysmenorrhoea ("severe menstral cramps, dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge") and allergy to metals ("nickel allergy").In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia"), migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced depression ("depression"), anxiety ("anxiety"), menorrhagia ("menstrual flow/ menorrhagia/abnormally severe bleeding during menstrual cycle/increased time period of bleeding during cycle"), vaginal haemorrhage ("vaginal bleeding"), mood swings ("mood swings/hormonal changes: mood swings") and emotional disorder ("emotional outbursts/ hormonal changes: emotional outbursts").In (b)(6) 2014, the patient experienced dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)") and nausea ("nausea").In (b)(6) 2014, the patient was found to have weight decreased ("severe weightless/ extreme weight loss").In (b)(6) 2014, the patient experienced abdominal pain lower ("cramping/lower abdominal pain/sever cramping/lower stomach pain"), back pain ("back pain/pain in my lower back") and genital pain ("genital pain/genital area pain").In 2014, the patient experienced dental caries ("dental problems/tooth decay").In (b)(6) 2014, the patient experienced rectal haemorrhage ("severe rectal bleeding") and diarrhoea ("diarrhea").In (b)(6) 2016, the patient experienced seizure ("seizures").On an unknown date, the patient experienced uterine haemorrhage (seriousness criteria hospitalization, medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), vaginal infection ("vaginal infection"), hypoaesthesia ("numbness"), paraesthesia ("tingling") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (hysterectomy (full), bilateral salpingectomy, hysterectomy with bilateral salpingectomy, total laparoscopic hysterectomy with bilateral salpingectomy and underwent a pelvic surgery, hysterectomy (full), bilateral salpingectomy) and had seven teeth pulled, plans to pull another ten teeth.Essure was removed on (b)(6) 2016.At the time of the report, the device expulsion, perforation, uterine haemorrhage, rectal haemorrhage, vaginal infection, hypoaesthesia, paraesthesia, depression, anxiety, weight decreased, abdominal pain upper, fatigue, diarrhoea, dysmenorrhoea, menorrhagia, vaginal discharge, weight increased, vaginal haemorrhage, mood swings, migraine, headache, nausea, allergy to metals, emotional disorder and dental caries outcome was unknown and the abdominal pain, genital haemorrhage, abdominal pain lower, dyspareunia, back pain, female sexual dysfunction, seizure and genital pain had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, anxiety, back pain, dental caries, depression, device expulsion, diarrhoea, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, female sexual dysfunction, genital haemorrhage, genital pain, headache, hypoaesthesia, menorrhagia, migraine, mood swings, nausea, paraesthesia, perforation, rectal haemorrhage, seizure, uterine haemorrhage, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.The reporter commented: on or about (b)(6) 2016, plaintiff sought medical attention for her symptons.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.8 kg/sqm.Imaging procedure - on (b)(6) 2013: essure coils were in place.Pathology test - on (b)(6) 2013: surgical pathology report: specimen: uterus, cervix, bilateral fallopian tubes.Diagnosis: total laparoscopic hysterectomy with bilateral salpingectomy: corpus uteri: superficial adenomyosis, interval endometrium, negative for hyperplasia and tumor.Bilateral fallopian tubes: no significant pathology.Negative for atypia and negative for tumor.Ultrasound scan - on (b)(6) 2013: results: an intrauterine device in the endometrial canal.Concerning the injuries in the case, the following ones were described in patient's medical records: dysmenorrhea, pelvic pain lot number ( 834802 ) is not valid.Lot number 834802 is not valid.Lot number: a33564 manufacture date: 2012-07 expiration date: 2015-07.Lot number: b34602 manufacture date: 2013-05 expiration date: 2016-05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-jul-2020: quality safety evaluation of ptc.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 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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