| Model Number ESS205 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Autoimmune Disorder (1732); Hypersensitivity/Allergic reaction (1907); Pain (1994); Perforation (2001); Tinnitus (2103); Uterine Perforation (2121); Vertigo (2134); Dizziness (2194); Urticaria (2278); Anxiety (2328); Depression (2361); Heavier Menses (2666); Bowel Perforation (2668); Foreign Body In Patient (2687); No Code Available (3191)
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| Event Date 01/01/2010 |
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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 food and drug administration (reference number: mw5067497) on (b)(6) 2017.The most recent information was received on (b)(6) 2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), allergy to metals ("nickel allergy/allergic reaction"), diabetes mellitus ("autoimmune diabetes"), autoimmune disorder ("autoimmune diabetes / autoimmune diseases") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included antihistamines, budesonide (nasacort) and iron (iron supplement).In 2006, the patient had essure (ess205) inserted.On (b)(6) 2009, the patient experienced endometriosis ("endometriosis"), menorrhagia ("heavy periods"), dysmenorrhoea ("painful periods"), vertigo ("vertigo") and tinnitus ("tinnitus").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), allergy to metals (seriousness criteria disability and medically significant) with urticaria, diabetes mellitus (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), dizziness ("dizziness"), depression ("depression") and anxiety ("anxiety").The patient was treated with surgery (to remove the essure implant).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, allergy to metals, diabetes mellitus, autoimmune disorder, genital haemorrhage, endometriosis, menorrhagia, dysmenorrhoea, vertigo, tinnitus, dizziness, depression and anxiety outcome was unknown.The reporter considered allergy to metals, anxiety, autoimmune disorder, depression, diabetes mellitus, dizziness, dysmenorrhoea, endometriosis, genital haemorrhage, menorrhagia, pelvic pain, tinnitus and vertigo to be related to essure (ess205).The reporter commented: consumer stated that she was never tested for nickel allergy before essure implantation.Consumer selected the serious criteria disability/permanent damage, intervention required and other serious (important medical event); however, she did not specify and/or assigned to one of the events in her narrative.Quality-safety evaluation of ptc: sample not available.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported relevant medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2017: follow up from summons- case upgraded as incident.Reporter lawyer was added.New events pain, dizziness, abnormal bleeding, depression and anxiety were added.Event allergic reaction was clubbed with earlier event.Product coding was updated according to date of product implant.Surgical treatment was added for the event pain.Product start and stop date was added.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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Spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("second tube reveals spiral metallic essure device firmly embedded within the proximal tube"), device dislocation ("essure device is not identified within the tube"), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), allergy to metals ("nickel allergy/allergic reaction"), diabetes mellitus ("autoimmune diabetes"), autoimmune disorder ("autoimmune diabetes / autoimmune diseases") and meniere's disease ("meneires disease") in a 26-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's past medical history included irritable bowel.Concurrent conditions included overweight, hot flashes, mood altered, sleeplessness, dehydration, vomiting, hypoglycemia, hyperglycemia, peripheral neuropathy, uterine bleeding, anemia and pelvic adhesions.Concomitant products included antihistamines, budesonide (nasocort) and iron (iron supplement).In 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced fatigue ("fatigue").On (b)(6) 2009, the patient experienced endometriosis ("endometriosis"), vertigo ("vertigo") and tinnitus ("tinnitus").In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), allergy to metals (seriousness criteria disability and medically significant) with urticaria, autoimmune disorder (seriousness criterion medically significant), menorrhagia ("heavy periods/ menorrhagia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), weight increased ("weight gain"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs") and alopecia ("hair loss").In 2011, the patient experienced dysmenorrhoea ("painful periods/ dysmenorrhea").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), diabetes mellitus (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), dizziness ("dizziness"), depression ("depression"), anxiety ("anxiety"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), abdominal pain ("right and left abdomen pain") and rash ("rash").The patient was treated with surgery ((b)(6) 2017, hysterectomy with bilateral salpingectomy), surgery ((b)(6) 2017, hysterectomy with bilateral salpingectomy), surgery ((b)(6) 2017, hysterectomy with bilateral salpingectomy) and surgery (ablation).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the device dislocation, pelvic pain, allergy to metals, diabetes mellitus, autoimmune disorder, meniere's disease, endometriosis, menorrhagia, dysmenorrhoea, vertigo, tinnitus, dizziness, depression, anxiety, vaginal haemorrhage, female sexual dysfunction, dyspareunia, fatigue, weight increased and irritable bowel syndrome outcome was unknown and the genital haemorrhage, nausea, alopecia, abdominal pain and rash had resolved.The reporter provided no causality assessment for device dislocation and embedded device with essure (ess205).The reporter considered abdominal pain, allergy to metals, alopecia, anxiety, autoimmune disorder, depression, diabetes mellitus, dizziness, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, irritable bowel syndrome, meniere's disease, menorrhagia, nausea, pelvic pain, rash, tinnitus, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: consumer stated that she was never tested for nickel allergy before essure implantation.Consumer selected the serious criteria disability/permanent damage, intervention required and other serious (important medical event); however, she did not specify and/or assigned to one of the events in her narrative.Current weight 150 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.8 kg/sqm.Pregnancy test - on (b)(6) 2017: negative.¿concerning the injuries reported in this case, the following one/ ones were described in patient¿s medical record; heavy periods, vertigo, minieres disease, dyspareunia, pelvic pain, endometriosis, nickel allergy, abdominal pain, menorrhagia, bleeding, device dislocation, device embedment.Quality-safety evaluation of ptc: sample not available.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported relevant medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: from pfs events " abnormal bleeding (vaginal), apareunia (inability to have sexual intercourse), meneires disease, nausea, nickel allergy, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, weight gain, gastrointestinal or digestive system condition type: ibs, hair loss, she did not performed essure confirmation test, rash, abdominal pain,essure device is not identified within the tube, second tube reveals spiral metallic essure device firmly embedded within the proximal tube." are added.Patient, reporter and product information are added.Concomitant and historical condition are added.Outcome of events "heavy bleeding, abdominal pain, hair loss, nausea, rash are recovered.Lab data added.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 embedded device ('second tube reveals spiral metallic essure device firmly embedded within the proximal tube'), device dislocation ('essure device is not identified within the tube'), bladder perforation ('the coils dislodged perforated her bowels and bladder.'), intestinal perforation ('the coils dislodged perforated her bowels and bladder.'), allergy to metals ('nickel allergy/allergic reaction'), genital haemorrhage ('abnormal bleeding'), autoimmune disorder ('autoimmune diabetes / autoimmune diseases'), meniere's disease ('meneires disease'), oesophageal ulcer haemorrhage (' a torn esophagus from prolonged vomiting from the vertigo and bleeding ulcers.'), aplastic anaemia ('aplastic anemia') and diabetes mellitus ('autoimmune diabetes') in a 26-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's medical history included irritable bowel and uterine ablation.Previously administered products included for an unreported indication: depo- provera in 2006.Concurrent conditions included overweight, hot flashes, mood altered, sleeplessness, dehydration, vomiting, hypoglycemia, hyperglycemia, peripheral neuropathy, uterine bleeding, anemia and pelvic adhesions.Concomitant products included antihistamines, budesonide (nasocort) and iron.In 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced fatigue ("fatigue").On (b)(6) 2009, the patient experienced endometriosis ("endometriosis"), vertigo ("vertigo") and tinnitus ("tinnitus").In 2010, the patient experienced allergy to metals (seriousness criterion disability) with urticaria, autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), menorrhagia ("heavy periods/ menorrhagia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs") and alopecia ("hair loss") and was found to have weight increased ("weight gain").In 2011, the patient experienced dysmenorrhoea ("painful periods/ dysmenorrhea").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), bladder perforation (seriousness criteria medically significant and intervention required), intestinal perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), meniere's disease (seriousness criterion medically significant), oesophageal ulcer haemorrhage (seriousness criterion medically significant), aplastic anaemia (seriousness criterion medically significant), diabetes mellitus (seriousness criterion medically significant), dizziness ("dizziness"), depression ("depression"), anxiety ("anxiety"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), abdominal pain ("right and left abdomen pain"), rash ("rash"), anger ("she has very severe bouts of rage"), impaired gastric emptying ("gastroparesis"), gluten sensitivity ("gluten intolerance"), mycotic allergy ("she was allergic to yeast"), dehydration ("dehydration") and panic disorder ("panic disorder").The patient was treated with surgery ((b)(6) 2017, hysterectomy with bilateral salpingectomy and ablation).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the device dislocation, bladder perforation, intestinal perforation, allergy to metals, autoimmune disorder, meniere's disease, oesophageal ulcer haemorrhage, aplastic anaemia, diabetes mellitus, endometriosis, pelvic pain, menorrhagia, dysmenorrhoea, vertigo, tinnitus, dizziness, depression, anxiety, vaginal haemorrhage, female sexual dysfunction, dyspareunia, fatigue, irritable bowel syndrome, anger, impaired gastric emptying, gluten sensitivity, mycotic allergy, dehydration and panic disorder outcome was unknown, the genital haemorrhage, nausea, alopecia, abdominal pain and rash had resolved and the weight increased was resolving.The reporter provided no causality assessment for device dislocation and embedded device with essure (ess205).The reporter considered abdominal pain, allergy to metals, alopecia, anger, anxiety, aplastic anaemia, autoimmune disorder, bladder perforation, dehydration, depression, diabetes mellitus, dizziness, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, gluten sensitivity, impaired gastric emptying, intestinal perforation, irritable bowel syndrome, meniere's disease, menorrhagia, mycotic allergy, nausea, oesophageal ulcer haemorrhage, panic disorder, pelvic pain, rash, tinnitus, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: consumer stated that she was never tested for nickel allergy before essure implantation.Consumer selected the serious criteria disability/permanent damage, intervention required and other serious (important medical event); however, she did not specify and/or assigned to one of the events in her narrative.Current weight 150 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.8 kg/sqm.Pregnancy test - on (b)(6) 2017: results: negative.¿concerning the injuries reported in this case, the following one/ ones were described in patient¿s medical record; heavy periods, vertigo, minieres disease, dyspareunia, pelvic pain, endometriosis, nickel allergy, abdominal pain, menorrhagia, bleeding, device dislocation, device embedment.¿concerning the injuries reported in this case, the following one/ ones were described in patient¿s social media, she has very severe bouts of rage, gastroparesis, a torn esophagus from prolonged vomiting from the vertigo and bleeding ulcers, the coils dislodged perforated her bowels and bladder, she was allergic to yeast, dehydration quality-safety evaluation of ptc: sample not available.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported relevant medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2019: social media received events " she has very severe bouts of rage, gastroparesis, a torn esophagus from prolonged vomiting from the vertigo and bleeding ulcers, the coils dislodged perforated her bowels and bladder, she was allergic to yeast, dehydration, aplastic anemia, panic disorder" were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: (b)(4)) on (b)(6) 2017.The most recent information was received on 10-jan-2020.This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('second tube reveals spiral metallic essure device firmly embedded within the proximal tube'), device dislocation ('essure device is not identified within the tube'), bladder perforation ('the coils dislodged perforated her bowels and bladder.'), intestinal perforation ('the coils dislodged perforated her bowels and bladder.') and genital haemorrhage ('abnormal bleeding') in a 26-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not performed essure confirmation test".The patient's medical history included irritable bowel and uterine ablation.Never had meniere's disease and anemia before essure.Previously administered products included for an unreported indication: depo- provera in 2006.Concurrent conditions included overweight, hot flashes, mood altered, sleeplessness, dehydration, vomiting, hypoglycemia, hyperglycemia, peripheral neuropathy, uterine bleeding, anemia and pelvic adhesions.Concomitant products included antihistamines, budesonide (nasocort) and iron.In 2007, the patient had essure (ess205) inserted.In 2009, the patient experienced fatigue ("fatigue").On (b)(6) 2009, the patient experienced endometriosis ("endometriosis"), vertigo ("vertigo") and tinnitus ("tinnitus").In 2010, the patient experienced autoimmune disorder ("autoimmune diabetes / autoimmune diseases"), pelvic pain ("pain"), menorrhagia ("heavy periods/ menorrhagia"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), nausea ("nausea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), irritable bowel syndrome ("gastrointestinal or digestive system condition type: ibs") and alopecia ("hair loss") and was found to have weight increased ("weight gain").In 2011, the patient experienced dysmenorrhoea ("painful periods/ dysmenorrhea").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), bladder perforation (seriousness criteria medically significant and intervention required), intestinal perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), meniere's disease ("meneires disease"), oesophageal ulcer haemorrhage ("a torn esophagus from prolonged vomiting from the vertigo and bleeding ulcers."), aplastic anaemia ("aplastic anemia"), diabetes mellitus ("autoimmune diabetes"), urticaria ("hives"), dizziness ("dizziness"), depression ("depression"), anxiety ("anxiety"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), abdominal pain ("right and left abdomen pain"), rash ("rash"), anger ("she has very severe bouts of rage"), impaired gastric emptying ("gastroparesis"), gluten sensitivity ("gluten intolerance"), mycotic allergy ("she was allergic to yeast"), dehydration ("dehydration"), panic disorder ("panic disorder"), crohn's disease ("chrones disease"), post-traumatic stress disorder ("post traumatic stress disorder"), muscular dystrophy ("md (muscular dystrophy)"), sleep apnoea syndrome ("obstructive sleep apnea"), mass ("little bumps on hand"), ulcer haemorrhage ("bleeding ulcer"), temporomandibular joint syndrome ("tmjd (temporomandibular joint dysfunction)") and allergy to metals ("nickel allergy/allergic reaction") and was found to have uterine leiomyoma ("fibroids").The patient was treated with surgery ((b)(6) 2017, hysterectomy with bilateral salpingectomy and ablation).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the device dislocation, bladder perforation, intestinal perforation, autoimmune disorder, meniere's disease, oesophageal ulcer haemorrhage, aplastic anaemia, diabetes mellitus, endometriosis, pelvic pain, menorrhagia, dysmenorrhoea, vertigo, urticaria, tinnitus, dizziness, depression, anxiety, vaginal haemorrhage, female sexual dysfunction, dyspareunia, fatigue, irritable bowel syndrome, anger, impaired gastric emptying, gluten sensitivity, mycotic allergy, dehydration, panic disorder, crohn's disease, post-traumatic stress disorder, muscular dystrophy, sleep apnoea syndrome, mass, ulcer haemorrhage, uterine leiomyoma, temporomandibular joint syndrome and allergy to metals outcome was unknown, the genital haemorrhage, nausea, alopecia, abdominal pain and rash had resolved and the weight increased was resolving.The reporter provided no causality assessment for device dislocation and embedded device with essure (ess205).The reporter considered abdominal pain, allergy to metals, alopecia, anger, anxiety, aplastic anaemia, autoimmune disorder, bladder perforation, crohn's disease, dehydration, depression, diabetes mellitus, dizziness, dysmenorrhoea, dyspareunia, endometriosis, fatigue, female sexual dysfunction, genital haemorrhage, gluten sensitivity, impaired gastric emptying, intestinal perforation, irritable bowel syndrome, mass, meniere's disease, menorrhagia, muscular dystrophy, mycotic allergy, nausea, oesophageal ulcer haemorrhage, panic disorder, pelvic pain, post-traumatic stress disorder, rash, sleep apnoea syndrome, temporomandibular joint syndrome, tinnitus, ulcer haemorrhage, urticaria, uterine leiomyoma, vaginal haemorrhage, vertigo and weight increased to be related to essure (ess205).The reporter commented: consumer stated that she was never tested for nickel allergy before essure implantation.Consumer selected the serious criteria disability/permanent damage, intervention required and other serious (important medical event); however, she did not specify and/or assigned to one of the events in her narrative.Current weight 150 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.8 kg/sqm.Pregnancy test - on (b)(6) 2017: results: negative.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record; heavy periods, vertigo, minieres disease, dyspareunia, pelvic pain, endometriosis, nickel allergy, abdominal pain, menorrhagia, bleeding, device dislocation, device embedment.¿concerning the injuries reported in this case, the following ones were described in patient¿s social media, she has very severe bouts of rage, gastroparesis, a torn esophagus from prolonged vomiting from the vertigo and bleeding ulcers, the coils dislodged perforated her bowels and bladder, she was allergic to yeast, dehydration quality-safety evaluation of ptc: sample not available.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, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported relevant medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2020: social media record received.Events¿ chrons disease, post traumatic stress disorder, md (muscular dystrophy), obstructive sleep apnea, little bumps on hand, bleeding ulcer, fibroids, and tmjd (temporomandibular joint dysfunction)¿ were added.Reporter was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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