| Model Number ESS205 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Diarrhea (1811); Gastritis (1874); Nausea (1970); Pain (1994); Rash (2033); Vomiting (2144)
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| Event Date 10/21/2006 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority fda ((b)(4)) on 22-aug-2015.The most recent information was received on 18-oct-2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and lupus-like syndrome ("symptoms of lupus") in a female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia") and polymorphic light eruption ("polymorphous light eruption").The patient was treated with surgery (removal of essure).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia and polymorphic light eruption outcome was unknown.The reporter considered diarrhoea, exfoliative rash, fibromyalgia, gastritis, lupus-like syndrome, pelvic pain and polymorphic light eruption to be related to essure (ess205).Quality-safety evaluation of ptc: final assessment.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 18-oct-2017: summons received- case become potentially legal, reporter information was added.Product start date and stop date was updated.Events pain was added.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type [?]initial' indicates here initial submission by the new legal manufacturer only.Company causality comment: 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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E was initially received via regulatory authority (fda, reference number: (b)(4)) on 22-aug-2015.The most recent information was received on 07-sep-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), procedural haemorrhage ("excessive bleeding during surgery") and lupus-like syndrome ("symptoms of lupus") in an adult female patient who had essure (ess205) (batch no.2265854-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's past medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii and parity 3 (set of twins).Concurrent conditions included uterine bleeding, bloating and constipation.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), peripheral swelling ("swelling in extremities"), arthralgia ("joint pain") and postoperative adhesion ("lot of adhesion").The patient was treated with surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, vaginal haemorrhage, menorrhagia, migraine, headache, dysmenorrhoea, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia and postoperative adhesion outcome was unknown.The reporter considered arthralgia, diarrhoea, dysmenorrhoea, exfoliative rash, fatigue, fibromyalgia, gastritis, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Diagnostic results: (b)(6) 2016:findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: mild chronic cervicitis with nabothian cysts.Benign endometrium with secretory features.Adenomyosis.Fallopian tubes with no significant pathologic changes.No malignancy is seen.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 7-sep-2018: quality-safety evaluation of product technical problem update.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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E was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-0729) on 22-aug-2015.The most recent information was received on 20-jun-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), procedural haemorrhage ("excessive bleeding during surgery") and lupus-like syndrome ("symptoms of lupus") in an adult female patient who had essure (ess205) (batch no.2265854) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's past medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii and parity 3 (set of twins).Concurrent conditions included uterine bleeding, bloating and constipation.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), peripheral swelling ("swelling in extremities"), arthralgia ("joint pain") and postoperative adhesion ("lot of adhesion").The patient was treated with surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, vaginal haemorrhage, menorrhagia, migraine, headache, dysmenorrhoea, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia and postoperative adhesion outcome was unknown.The reporter considered arthralgia, diarrhoea, dysmenorrhoea, exfoliative rash, fatigue, fibromyalgia, gastritis, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Diagnostic results: 09-aug-2016:findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: - mild chronic cervicitis with nabothian cysts.- benign endometrium with secretory features.- adenomyosis.- fallopian tubes with no significant pathologic changes.- no malignancy is seen.Quality-safety evaluation of ptc: final assessment since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.Medical assessment no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 20-jun-2018: plaintiff fact sheet received.Events vaginal, menorrhagia,migraines / headaches, dysmenorrhea, vaginal discharge; fatigue; weight gain, swelling in extremities & adhesion are added.Lot number & lab data updated.Concomitant & historical conditions drugs were added.Product, patient & reporter information updated.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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E was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-0729) on 22-aug-2015.The most recent information was received on 02-oct-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), procedural haemorrhage ("excessive bleeding during surgery"), lupus-like syndrome ("symptoms of lupus") and genital haemorrhage ("heavy bleeding") in an adult female patient who had essure (ess205) (batch no.2265854-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's past medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii and parity 3 (set of twins).Concurrent conditions included uterine bleeding, bloating and constipation.On (b)(6) 2004, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), peripheral swelling ("swelling in extremities"), arthralgia ("joint pain"), postoperative adhesion ("lot of adhesion"), back pain ("lower back pain"), abdominal pain ("abdominal pain") and genital haemorrhage (seriousness criterion medically significant).The patient was treated with surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on 9-aug-2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, vaginal haemorrhage, menorrhagia, migraine, headache, dysmenorrhoea, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia, postoperative adhesion, back pain, abdominal pain and genital haemorrhage outcome was unknown.The reporter considered abdominal pain, arthralgia, back pain, diarrhoea, dysmenorrhoea, exfoliative rash, fatigue, fibromyalgia, gastritis, genital haemorrhage, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Diagnostic results: 09-aug-2016:findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: - mild chronic cervicitis with nabothian cysts.- benign endometrium with secretory features.- adenomyosis.- fallopian tubes with no significant pathologic changes.- no malignancy is seen.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received- new event lower back pain, abdominal pain, heavy bleeding were 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 case was initially received via regulatory authority (fda, reference number: (b)(4)) on (b)(6) 2015.The most recent information was received on 14-jan-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), genital haemorrhage ("heavy bleeding"), procedural haemorrhage ("excessive bleeding during surgery") and lupus-like syndrome ("symptoms of lupus") in a 23-year-old female patient who had essure (ess205) (batch no.2265854-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii, parity 3 (set of twins), gallbladder sludge and cholecystectomy.(b)(6) 2016: findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: - mild chronic cervicitis with nabothian cysts.- benign endometrium with secretory features.- adenomyosis.- fallopian tubes with no significant pathologic changes.- no malignancy is seen.Previously administered products included for birth control: depo-provera.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included uterine bleeding, bloating, constipation and gerd since 2012.Concomitant products included ethinylestradiol;norgestimate (ortho tri-cyclen) for birth control.On (b)(6) 2004, the patient had essure (ess205) inserted.In (b)(6) 2004, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), peripheral swelling ("swelling in extremities"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating") and coital bleeding ("postcoital bleeding") and was found to have weight increased ("weight gain").On (b)(6) 2004, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 17 days after insertion of essure (ess205).On (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), procedural haemorrhage (seriousness criterion medically significant), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), arthralgia ("joint pain"), postoperative adhesion ("lot of adhesion"), back pain ("lower back pain") and abdominal pain ("abdominal pain").The patient was treated with nsaids, thyroid (armour thyroid), triamcinolone acetonide (kenalog) and surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, migraine, headache, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia, postoperative adhesion, abdominal pain, dyspareunia and coital bleeding outcome was unknown and the genital haemorrhage, vaginal haemorrhage, menorrhagia, dysmenorrhoea, back pain and abdominal distension had resolved.The reporter considered abdominal distension, abdominal pain, arthralgia, back pain, coital bleeding, diarrhoea, dysmenorrhoea, dyspareunia, exfoliative rash, fatigue, fibromyalgia, gastritis, genital haemorrhage, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Current weight 312 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 14-jan-2019: pfs received: patient height was added.Events: dyspareunia, bloating, coital bleeding were added.Event onset date and outcome were updated.Medical history were added.Treatment drugs 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 case was initially received via regulatory authority (fda, reference number: fda-(b)(4)) on 22-aug-2015.The most recent information was received on 27-nov-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain'), genital haemorrhage ('heavy bleeding'), procedural haemorrhage ('excessive bleeding during surgery') and lupus-like syndrome ('symptoms of lupus') in a 23-year-old female patient who had essure (ess205) (batch no.2265854-notvalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii, parity 3 (set of twins), gallbladder sludge and cholecystectomy.(b)(6) 2016:findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: mild chronic cervicitis with nabothian cysts.Benign endometrium with secretory features.Adenomyosis.Fallopian tubes with no significant pathologic changes.No malignancy is seen.Previously administered products included for birth control: depo-provera.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included gerd since 2012, uterine bleeding, bloating and constipation.Concomitant products included ethinylestradiol;norgestimate (ortho tri-cyclen) for birth control.On (b)(6) 2004, the patient had essure (ess205) inserted.In (b)(6) 2004, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), peripheral swelling ("swelling in extremities"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating") and coital bleeding ("postcoital bleeding") and was found to have weight increased ("weight gain").On (b)(6) 2004, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 17 days after insertion of essure (ess205).On (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), procedural haemorrhage (seriousness criterion medically significant), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), arthralgia ("joint pain"), postoperative adhesion ("lot of adhesion"), back pain ("lower back pain") and abdominal pain ("abdominal pain").The patient was treated with nsaids, thyroid (armour thyroid), triamcinolone acetonide (kenalog) and surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, migraine, headache, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia, postoperative adhesion, abdominal pain, dyspareunia and coital bleeding outcome was unknown and the genital haemorrhage, vaginal haemorrhage, menorrhagia, dysmenorrhoea, back pain and abdominal distension had resolved.The reporter considered abdominal distension, abdominal pain, arthralgia, back pain, coital bleeding, diarrhoea, dysmenorrhoea, dyspareunia, exfoliative rash, fatigue, fibromyalgia, gastritis, genital haemorrhage, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Current weight 312 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 27-nov-2019: the case (b)(4) (mfr# 2951250-2019-11769) was identified as a follow up of this case.Therefore, the case (b)(4) was deleted from argus database.No new information.Incident no valid 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 case was initially received via regulatory authority (fda, reference number: (b)(4)) on (b)(6) 2015.The most recent information was received on 20-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and lupus-like syndrome ('symptoms of lupus') in a 23-year-old female patient who had essure (ess205) (batch no.2265854-notvalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not perform essure confirmation test".The patient's medical history included arthritis, fibromyalgia, migraine, osteoarthritis, hypothyroidism, gravida ii, parity 3 (set of twins), gallbladder sludge and cholecystectomy.(b)(6) 2016:findings: normal uterus, tubes with essure coils in place bilaterally.Normal ovaries.Specimen removed: uterus, cervix, tubes.Assessment: from tvh/bs for aub.Doing well.Diagnosis: uterus, cervix and bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: - mild chronic cervicitis with nabothian cysts.- benign endometrium with secretory features.- adenomyosis.- fallopian tubes with no significant pathologic changes.- no malignancy is seen.Previously administered products included for birth control: depo-provera.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included gerd since 2012, uterine bleeding, bloating and constipation.Concomitant products included ethinylestradiol;norgestimate (ortho tri-cyclen) for birth control.On (b)(6) 2004, the patient had essure (ess205) inserted.In (b)(6) 2004, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), headache ("migraines / headaches"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), peripheral swelling ("swelling in extremities"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating") and coital bleeding ("postcoital bleeding") and was found to have weight increased ("weight gain").On (b)(6) 2004, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 17 days after insertion of essure (ess205).On (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), procedural haemorrhage ("excessive bleeding during surgery"), lupus-like syndrome (seriousness criterion medically significant), diarrhoea ("diarrhea"), gastritis ("diagnosis of gastritis") with nausea and vomiting, exfoliative rash ("flaky rash on my abdomen on my face, on my legs"), fibromyalgia ("fibromyalgia"), polymorphic light eruption ("polymorphous light eruption"), arthralgia ("joint pain"), postoperative adhesion ("lot of adhesion"), back pain ("lower back pain"), abdominal pain ("abdominal pain") and photosensitivity reaction ("sun allergy").The patient was treated with nsaids, thyroid (armour thyroid), triamcinolone acetonide (kenalog) and surgery (total vaginal hysterectomy, bilateral salpingectomy.).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, procedural haemorrhage, lupus-like syndrome, diarrhoea, gastritis, exfoliative rash, fibromyalgia, polymorphic light eruption, migraine, headache, vaginal discharge, fatigue, weight increased, peripheral swelling, arthralgia, postoperative adhesion, abdominal pain, dyspareunia, coital bleeding and photosensitivity reaction outcome was unknown and the genital haemorrhage, vaginal haemorrhage, menorrhagia, dysmenorrhoea, back pain and abdominal distension had resolved.The reporter considered abdominal distension, abdominal pain, arthralgia, back pain, coital bleeding, diarrhoea, dysmenorrhoea, dyspareunia, exfoliative rash, fatigue, fibromyalgia, gastritis, genital haemorrhage, headache, lupus-like syndrome, menorrhagia, migraine, pelvic pain, peripheral swelling, photosensitivity reaction, polymorphic light eruption, postoperative adhesion, procedural haemorrhage, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure (ess205).The reporter commented: initially, to assure tubal sterilization, the patient as placed on her right side, leaving 3 coils.And then lacing on the left side and leaving 4 coils.Current weight 312 lbs.Concerning the injuries reported in this case, the following ones were reported via social media :photosensitivity reaction.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority, consumer, consumer, consumer, other or consumer is not possible.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media content received: reporter added.Event : sun allergy added.Seriousness criteria (medically significant) of event genital hemorrhage was removed.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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Search Alerts/Recalls
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