| Model Number ESS305 |
| Device Problems
Malposition of Device (2616); Insufficient Information (3190)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Uterine Perforation (2121); Weight Changes (2607); Foreign Body In Patient (2687)
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| Event Date 07/01/2013 |
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Event Type
Injury
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Event Description
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A consumer reported that she had essure inserted on (b)(6) 2013 and about two months later began experiencing losing hair, migraines, gaining 30 lbs, and horrible bleeding.She went to the emergency room and was placed on an unspecified hormone to stop the bleeding.A sonogram and pelvic x-ray revealed one coil embedded in her uterus and the other coil embedded in a fallopian tube.A hysterectomy was performed on (b)(6) 2014, which also removed essure.Consumer states that she has since lost 8 lbs and her migraines have resolved.
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Manufacturer Narrative
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Follow-up information was received on 11-jul-2014: the case (b)(4) was found to be duplicate of (b)(4).All information was transferred to this case.The local health authority was added as reporter under the reference number mw5033766 and mw5034610.On (b)(6) 2013 essure lot number a96180 was implanted.She felt that she was slowly being poisoned, cannot sleep and hard to focus (in a fog/dizzy), experienced back and stomach pain, diarrhea constantly, bloating, stabbing pains in her abdominal area, acne, feels vibrating/pulsating where the coils are, skin so different, breaking out/ rashes/blistering under jewelry, exhausted daily, horrible periods, moody.Consumer considers the events were related to essure.Ptc investigation result was received on 16-jul-2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: (b)(6) case opened since lot number was received.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 confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.Two (2) additional ae case reports have been received to date in relation to batch number a96180 but none of these cases refer to a similar type of medical event.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for a technical investigation.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced one coil was embedded in the uterus (device dislocation), horrible bleeding / severe bleeding and other was embedded in the fallopian tube.This case is not medically confirmed.All these events were considered serious as medically significant, listed according to reference safety information for essure.This case was regarded as incident since hysterectomy was performed to remove essure.Bleeding and dislocation may occur after essure insertion.There is also a possibility that patient experienced bleeding after essure micro-insert placement procedure.During difficult insertions the device may stay embedded in the fallopian tube.In the present case was stated that she was placed on hormone for 10 days to stop bleeding.A sonogram and pelvic x-ray was performed and it showed that one coil was embedded in the uterus, and the other was embedded in the fallopian tube.Based on available information received the events above were assessed as related to essure therapy.Additionally other non -serious events were reported.Ptc final analysis, after received the lot number, the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.
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Manufacturer Narrative
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This case was initially received via regulatory authority food and drug administration (reference number: mw5033766) on 19-feb-2014.The most recent information was received on 04-jan-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of embedded device ("perforation one coil was embedded in the uterus \other was embedded in the fallopian tube"), genital haemorrhage ("horrible bleeding / severe bleeding / blood clots"), device dislocation ("essure device migrated from consumer¿s fallopian tubes to her uterus/rectum"), autoimmune disorder ("auto immune disorders") and pregnancy with contraceptive device ("pregnancy") in a (b)(6) female patient (gravida 2, para 1) who had essure (batch no.A96180) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "defective condition of essure".The patient's past medical history included gravida ii, parity 1 ((b)(6) 1997), asthma, unspecified, cholecystectomy and abdominoplasty.Patient denies having any allergies.Previously administered products included for an unreported indication: dexamethasone and toradol.Concurrent conditions included body mass index normal and alcoholic.Family history included stroke.Concomitant products included anaesthetics (anesthesia), biotin, calcium, cilest (ortho tri-cyclen) on (b)(6) 2012, colecalciferol (vitamin d3), cyanocobalamin (vitamin b12), oxycodone and zinc acetate.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced back pain ("back pain \ lower back pain").In (b)(6) 2013, the patient experienced genital haemorrhage (seriousness criterion hospitalization), alopecia ("losing hair"), migraine ("had migraines") and weight increased ("was gaining (b)(6)lbs").On an unknown date, the patient experienced embedded device (seriousness criteria hospitalization, medically significant and intervention required) with abdominal pain, abdominal pain lower and pelvic pain, device dislocation (seriousness criteria hospitalization and intervention required), autoimmune disorder (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), device expulsion ("one coil was embedded in the uterus"), feeling abnormal ("felt that she was slowly being poisoned"), insomnia ("cannot sleep and hard to focus (in a fog/dizzy)"), disturbance in attention ("cannot sleep and hard to focus (in a fog/dizzy)"), abdominal pain upper ("stomach pain"), diarrhoea ("diarrhea"), medical device discomfort ("feel vibrating/pulsating where the coils are"), dermatitis contact ("skin so different, breaking out/rashes/blistering under jewelry"), fatigue ("exhausted daily \feeling very exhausted and not herself"), menstrual disorder ("horrible periods \ abnormal periods"), mood altered ("moody"), abdominal distension ("bloating"), hypersensitivity ("allergic reaction") with blister, rash and acne, adhesion ("adhesion disorders"), pain ("mental and physical pain \ head to toe pain"), emotional distress ("mental and physical pain \ head to toe pain"), injury ("serious injuries / severe injuries / permanent injuries"), depression ("depression"), anxiety ("anxiety"), muscle spasms ("muscle spasms") and inflammation ("inflammation").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (full hysterectomy) and surgery.Essure was removed on (b)(6) 2014.At the time of the report, the embedded device, genital haemorrhage, alopecia, migraine, weight increased, device expulsion, feeling abnormal, insomnia, disturbance in attention, abdominal pain upper, diarrhoea, back pain, medical device discomfort, dermatitis contact, fatigue, menstrual disorder, mood altered, abdominal distension and hypersensitivity had resolved and the device dislocation, autoimmune disorder, pregnancy with contraceptive device, adhesion, pain, emotional distress, injury, depression, anxiety, muscle spasms and inflammation outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal distension, abdominal pain upper, adhesion, alopecia, anxiety, autoimmune disorder, back pain, depression, dermatitis contact, device dislocation, device expulsion, diarrhoea, disturbance in attention, embedded device, emotional distress, fatigue, feeling abnormal, genital haemorrhage, hypersensitivity, inflammation, injury, insomnia, medical device discomfort, menstrual disorder, mood altered, muscle spasms, pain, pregnancy with contraceptive device and weight increased to be related to essure.The reporter provided no causality assessment for migraine with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.5 kg/sqm.Abdominal x-ray - on an unknown date: perforation.Hysterosalpingogram - on an unknown date: essure confirmation test.Ultrasound pelvis - on (b)(6) 2014: essure coils inappropriately located.Quality-safety evaluation of ptc: final assessment: child case opened since lot number was received.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 confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.Two (2) additional ae case reports have been received to date in relation to batch number a96180 but none of these cases refer to a similar type of medical event.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for a technical investigation.At the time of this medical assessment the technical investigation concluded unconfirmed quality defect.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 2018: correction following company internal coding review, the event mental and physical pain \ head to toe pain was split into mental pain (mental distress) and physical pain \ head to toe pain (general body pain).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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Follow up information received on 10-dec-2014 from lawyer (legal case): according to the civil action complaint, the physician that implanted essure was trained on how to use this device and other hysteroscopic equipment.After being implanted with essure, the plaintiff began to suffer from weight gain, severe bleeding, skin blister, rashes, severe abdominal pain and hair loss.As a result, she was hospitalized on several occasions.At time of the report, the plaintiff suffered from auto-immune and adhesions disorders.It was also reported that the plaintiff had to undergo numerous surgical procedures, diagnostic procedures.Plaintiff sustained significant pain and suffering, both physical and mental, and will continue to do so into the indefinite future.It was stated the defective condition of essure was the factual cause of consumer's hysterectomy and pregnancy; and cause of the severe and permanent injuries.Essure device migrated from consumer's fallopian tubes to her uterus/rectum, requiring five hospitalizations and an eventual hysterectomy.The hysterectomy was performed on or about (b)(6) 2014.According to the complaint, the essure caused the plaintiff to be hospitalized on several occasions and suffer damages including weight gain, severe bleeding, skin blisters, rashes, severe abdominal pain and hair loss.Eventually, the plaintiff had to undergo a hysterectomy as one of the coils migrated into her uterus.Company causality comment: this non-medically confirmed legal case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted and had essure device migrated from fallopian tubes to her uterus/rectum, one coil embedded in the uterus, other was embedded in the fallopian tube, stabbing pains in her abdominal area / severe abdominal pain and horrible bleeding / severe bleeding.All these events were considered serious due to hospitalization and listed according to essure's reference safety information, except for auto-immune disorders, considered serious due to medical importance and unlisted.In this particular case, the event auto-immune disorders is the only serious event that has no clear temporal relationship with essure.Therefore, the causality between this event and essure cannot be assessed.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.As it is not possible to determine if the pregnancy occurred as a consequence of a malpositioned insert or ineffective device, the pregnancy was considered related to essure.All other events occurred after essure insertion.Considering the nature of these events and positive temporal relationship, essure migration, embedment in uterus and tube, abdominal pain and genital bleedings were assessed as related to essure.The case was regarded as incident due to hysterectomy performed to remove essure and hospitalization caused by essure.Non-serious events were also reported.Initial product technical complaint concluded there is no reason to suspect a quality defect, however, a new ptc analysis which includes new events is expected.This is a legal case.No active follow-up will be done because further information will be received through litigation process.
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Manufacturer Narrative
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Follow up information received on 12-jan-2015: no new information was provided.Case considered closed on 13-apr-2015.Company causality comment: this non-medically confirmed, legal case report refers to a (b)(6) female plaintiff who had essure (fallopian tube occlusion insert) inserted and essure device migrated from fallopian tubes to her uterus/rectum, one coil was embedded in the uterus and other was embedded in the fallopian tube.Additionally, she had stabbing pains in her abdominal area / severe abdominal pain; horrible bleeding / severe bleeding and a pregnancy with essure.All these events were considered serious due to hospitalization and are listed according to essure's reference safety information, except for auto-immune disorders, which is unlisted and pregnancy which was considered non-serious.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.As it is not possible to determine if the pregnancy occurred as a consequence of a malpositioned insert or ineffective device, it was considered related to essure in this case.Due to the nature of the event auto-immune disorders and considering essure local action at fallopian tubes, causality is considered very unlikely.Regarding the remaining events, given their nature and positive temporal relationship, causality with essure cannot be excluded.The case was regarded as incident due to hysterectomy performed to remove essure and hospitalization.Non-serious events were also reported.A product technical analysis was performed and concluded there is no reason to suspect a quality defect.This is a legal case; further information will be received through litigation process.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This case was initially received via regulatory authority food and drug administration (reference number: mw5033766) on 19-feb-2014.The most recent information was received on 04-dec-2017.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of embedded device ("perforation one coil was embedded in the uterus \other was embedded in the fallopian tube\ "), genital haemorrhage ("horrible bleeding / severe bleeding / blood clots"), device dislocation ("essure device migrated from consumer¿s fallopian tubes to her uterus/rectum"), autoimmune disorder ("auto immune disorders") and pregnancy with contraceptive device ("pregnancy") in a (b)(6) female patient (gravida 2, para 1) who had essure (batch no.A96180) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "defective condition of essure".The patient's past medical history included gravida ii, parity 1 ((b)(6) 1997), asthma, unspecified, cholecystectomy and abdominoplasty.Patient denies having any allergies.Previously administered products included for an unreported indication: dexamethasone and toradol.Concurrent conditions included body mass index normal and alcoholic.Family history included stroke.Concomitant products included anaesthetics (anesthesia), biotin, cilest (ortho tri-cyclen) on (b)(6) 2012, cholecalciferol (vitamin d3), cyanocobalamin (vitamin b12), oxycodone and zinc acetate.On an unknown date, the patient started calcium at an unspecified dose and frequency.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced back pain ("back pain \ lower back pain").In (b)(6) 2013, the patient experienced genital haemorrhage (seriousness criterion hospitalization), alopecia ("losing hair"), migraine ("had migraines") and weight increased ("was gaining (b)(6) lbs").On an unknown date, the patient experienced embedded device (seriousness criteria hospitalization, medically significant and intervention required) with abdominal pain, abdominal pain lower and pelvic pain, device dislocation (seriousness criteria hospitalization and intervention required), autoimmune disorder (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), device expulsion ("one coil was embedded in the uterus"), feeling abnormal ("felt that she was slowly being poisoned"), insomnia ("cannot sleep and hard to focus (in a fog/dizzy)"), disturbance in attention ("cannot sleep and hard to focus (in a fog/dizzy)"), abdominal pain upper ("stomach pain"), diarrhoea ("diarrhea"), medical device discomfort ("feel vibrating/pulsating where the coils are"), dermatitis contact ("skin so different, breaking out/rashes/blistering under jewelry"), fatigue ("exhausted daily \feeling very exhausted and not herself"), menstrual disorder ("horrible periods \ abnormal periods"), mood altered ("moody"), abdominal distension ("bloating"), hypersensitivity ("allergic reaction") with blister,acne and rash, adhesion ("adhesion disorders"), pain ("mental and physical pain \ head to toe pain"), injury ("serious injuries / severe injuries / permanent injuries"), depression ("depression"), anxiety ("anxiety"), muscle spasms ("muscle spasms") and inflammation ("inflammation").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with surgery (full hysterectomy) and surgery.Essure was removed on (b)(6) 2014.At the time of the report, the embedded device, genital haemorrhage, alopecia, migraine, weight increased, device expulsion, feeling abnormal, insomnia, disturbance in attention, abdominal pain upper, diarrhoea, back pain, medical device discomfort, dermatitis contact, fatigue, menstrual disorder, mood altered, abdominal distension and hypersensitivity had resolved and the device dislocation, autoimmune disorder, pregnancy with contraceptive device, adhesion, pain, injury, depression, anxiety, muscle spasms and inflammation outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal distension, abdominal pain upper, adhesion, alopecia, anxiety, autoimmune disorder, back pain, depression, dermatitis contact, device dislocation, device expulsion, diarrhoea, disturbance in attention, embedded device, fatigue, feeling abnormal, genital haemorrhage, hypersensitivity, inflammation, injury, insomnia, medical device discomfort, menstrual disorder, mood altered, muscle spasms, pain, pregnancy with contraceptive device and weight increased to be related to essure.The reporter provided no causality assessment for migraine with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.5 kg/sqm.Abdominal x-ray - on an unknown date: perforation.Hysterosalpingogram - on an unknown date: essure confirmation test.Ultrasound pelvis - on (b)(6) 2014: essure coils inappropriately located.Quality-safety evaluation of ptc: final assessment: child case opened since lot number was received.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 confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.Two (2) additional ae case reports have been received to date in relation to batch number a96180 but none of these cases refer to a similar type of medical event.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for a technical investigation.At the time of this medical assessment the technical investigation concluded unconfirmed quality defect.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 2017: pfs received, reporter added, event embedment replaced with perforation, events added as follows;-depression, anxiety, allergic reaction, cramping, historical condition and concomitant drug added, family history, historical drug added.Essure legal manufacture has changed from bayer healthcare, llc, (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.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 (food and drug administration, reference number: (b)(4)) on 19-feb-2014.The most recent information was received on 27-jun-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of embedded device ("perforation one coil was embedded in the uterus \other was embedded in the fallopian tube\ "), genital haemorrhage ("horrible bleeding / severe bleeding / blood clots"), device dislocation ("essure device migrated from consumer¿s fallopian tubes to her uterus/rectum"), autoimmune disorder ("auto immune disorders") and pregnancy with contraceptive device ("pregnancy") in a (b)(6) female patient (gravida 2, para 1) who had essure (batch no.A96180) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "defective condition of essure".The patient's past medical history included gravida ii, parity 1 ((b)(6) 1997), asthma, unspecified, cholecystectomy and abdominoplasty.Patient denies having any allergies.Previously administered products included for an unreported indication: dexamethasone and toradol.Concurrent conditions included body mass index increased and alcoholic.Family history included stroke.Concomitant products included anaesthetics (anesthesia), biotin, calcium, cilest (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) 2014, colecalciferol (vitamin d3), cyanocobalamin (vitamin b12), oxycodone and zinc acetate.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced back pain ("back pain \ lower back pain").In (b)(6) 2013, the patient experienced genital haemorrhage (seriousness criterion hospitalization), alopecia ("losing hair"), migraine ("had migraines") and weight increased ("was gaining (b)(6)lbs").On an unknown date, the patient experienced embedded device (seriousness criteria hospitalization, medically significant and intervention required) with abdominal pain, abdominal pain lower and pelvic pain, device dislocation (seriousness criteria hospitalization and intervention required), autoimmune disorder (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), device expulsion ("one coil was embedded in the uterus"), feeling abnormal ("felt that she was slowly being poisoned"), insomnia ("cannot sleep and hard to focus (in a fog/dizzy)"), disturbance in attention ("cannot sleep and hard to focus (in a fog/dizzy)"), abdominal pain upper ("stomach pain"), diarrhoea ("diarrhea"), medical device discomfort ("feel vibrating/pulsating where the coils are"), dermatitis contact ("skin so different, breaking out/rashes/blistering under jewelry"), fatigue ("exhausted daily \feeling very exhausted and not herself"), menstrual disorder ("horrible periods \ abnormal periods"), mood altered ("moody"), abdominal distension ("bloating"), hypersensitivity ("allergic reaction") with blister, rash and acne, adhesion ("adhesion disorders"), pain ("mental and physical pain \ head to toe pain"), emotional distress ("mental and physical pain \ head to toe pain"), injury ("serious injuries / severe injuries / permanent injuries"), depression ("depression"), anxiety ("anxiety"), muscle spasms ("muscle spasms") and inflammation ("inflammation").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (full hysterectomy) and surgery.Essure was removed on (b)(6) 2014.At the time of the report, the embedded device, genital haemorrhage, alopecia, migraine, weight increased, device expulsion, feeling abnormal, insomnia, disturbance in attention, abdominal pain upper, diarrhoea, back pain, medical device discomfort, dermatitis contact, fatigue, menstrual disorder, mood altered, abdominal distension and hypersensitivity had resolved and the device dislocation, autoimmune disorder, pregnancy with contraceptive device, adhesion, pain, emotional distress, injury, depression, anxiety, muscle spasms and inflammation outcome was unknown.The pregnancy outcome was not reported.The reporter provided no causality assessment for migraine with essure.The reporter considered abdominal distension, abdominal pain upper, adhesion, alopecia, anxiety, autoimmune disorder, back pain, depression, dermatitis contact, device dislocation, device expulsion, diarrhoea, disturbance in attention, embedded device, emotional distress, fatigue, feeling abnormal, genital haemorrhage, hypersensitivity, inflammation, injury, insomnia, medical device discomfort, menstrual disorder, mood altered, muscle spasms, pain, pregnancy with contraceptive device and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.5 kg/sqm.Abdominal x-ray - on an unknown date: perforation.Hysterosalpingogram - on an unknown date: essure confirmation test.Ultrasound pelvis - on (b)(6) 2014: essure coils inappropriately located.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jun-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 case was initially received via regulatory authority (food and drug administration, reference number: mw5033766) on 19-feb-2014.The most recent information was received on 23-jul-2018.This retrospective pregnancy case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure perforated left fallopian tube"), embedded device ("perforation one coil was embedded in the uterus \ other was embedded in the fallopian tube"), genital haemorrhage ("horrible bleeding / severe bleeding / blood clots"), device dislocation ("essure device migrated from consumer¿s fallopian tubes to her uterus/rectum"), autoimmune disorder ("auto immune disorders") and pregnancy with contraceptive device ("pregnancy") in a (b)(6) female patient (gravida 2, para 1) who had essure (batch no.A96180) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "defective condition of essure".The patient's past medical history included gravida ii, parity 1 ((b)(6) 1997), asthma, unspecified, cholecystectomy and abdominoplasty.Patient denies having any allergies.Previously administered products included for an unreported indication: dexamethasone and toradol.Concurrent conditions included body mass index increased, alcoholic, itching, dysmenorrhea, urinary urgency, dizziness, nausea, dysfunctional uterine haemorrhage, uterine leiomyoma and rectal bleeding.Family history included stroke.Concomitant products included anaesthetics (anesthesia), biotin, calcium, cilest (ortho tri-cyclen) from (b)(6) 2012 to (b)(6) 2014, colecalciferol (vitamin d3), cyanocobalamin (vitamin b12), oxycodone and zinc acetate.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced back pain ("back pain \ lower back pain") and pain ("mental and physical pain \ head to toe pain /soreness").In (b)(6) 2013, the patient experienced genital haemorrhage (seriousness criterion hospitalization), alopecia ("losing hair"), migraine ("had migraines") and weight increased ("was gaining (b)(6)lbs").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria hospitalization, medically significant and intervention required) with abdominal pain, abdominal pain lower and pelvic pain, device dislocation (seriousness criteria hospitalization and intervention required), autoimmune disorder (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), medical device discomfort ("feel vibrating/pulsating where the coils are"), device expulsion ("one coil was embedded in the uterus"), feeling abnormal ("felt that she was slowly being poisoned / brain fog"), insomnia ("cannot sleep and hard to focus (in a fog/dizzy)"), disturbance in attention ("cannot sleep and hard to focus (in a fog/dizzy)"), abdominal pain upper ("stomach pain"), diarrhoea ("diarrhea"), dermatitis contact ("skin so different, breaking out/rashes/blistering under jewelry"), fatigue ("exhausted daily \feeling very exhausted and not herself"), menstrual disorder ("horrible periods \ abnormal periods"), mood altered ("moody"), abdominal distension ("bloating"), hypersensitivity ("allergic reaction") with blister, rash and acne, adhesion ("adhesion disorders"), emotional distress ("mental and physical pain \ head to toe pain"), injury ("serious injuries / severe injuries / permanent injuries"), depression ("depression"), anxiety ("anxiety"), muscle spasms ("muscle spasms"), inflammation ("inflammation"), headache ("headaches"), mood swings ("mood swing") and allergy to metals ("allergic reaction to earrings, necklaces and rings").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery (lavh with bilateral salpingectomy; cystoscopy), surgery (full hysterectomy) and surgery.Essure was removed on (b)(6) 2014.At the time of the report, the fallopian tube perforation, device dislocation, autoimmune disorder, pregnancy with contraceptive device, adhesion, emotional distress, injury, depression, anxiety, muscle spasms, inflammation, headache, mood swings and allergy to metals outcome was unknown and the embedded device, genital haemorrhage, medical device discomfort, alopecia, migraine, weight increased, device expulsion, feeling abnormal, insomnia, disturbance in attention, abdominal pain upper, diarrhoea, back pain, dermatitis contact, fatigue, menstrual disorder, mood altered, abdominal distension, hypersensitivity and pain had resolved.The pregnancy outcome was not reported.The reporter provided no causality assessment for migraine with essure.The reporter considered abdominal distension, abdominal pain upper, adhesion, allergy to metals, alopecia, anxiety, autoimmune disorder, back pain, depression, dermatitis contact, device dislocation, device expulsion, diarrhoea, disturbance in attention, embedded device, emotional distress, fallopian tube perforation, fatigue, feeling abnormal, genital haemorrhage, headache, hypersensitivity, inflammation, injury, insomnia, medical device discomfort, menstrual disorder, mood altered, mood swings, muscle spasms, pain, pregnancy with contraceptive device and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.5 kg/sqm.Abdominal x-ray - on (b)(6) 2013: perforation.Hysterosalpingogram - on (b)(6) 2013: essure confirmation test ultrasound pelvis - on (b)(6) 2014: essure coils inappropriately located.Concerning the injuries reported in this case, the following one/ones was/were described/confirmed in patient¿s medical records/social media: cramping, pain, embedded device, abdominal pain, pelvic pain, hair loss, rash, feeling abnormal, migraine, mood swings, physical exhaustion, insomnia, weight gain, genital haemorrhage, device expulsion, diarrhoea, back pain, abdominal distension".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received - new event "headaches, essure perforated left fallopian tube, mood swing, allergic reaction to earrings, necklaces and rings," were added.Historical and concomitant conditions were added.Lab data was updated.New reporter 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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Search Alerts/Recalls
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