| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Myalgia (2238); Anxiety (2328); Depression (2361); Abdominal Cramps (2543); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)
|
| Event Date 01/01/2008 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ("lower abdomen cramping pain/severe and persistent cramping in my lower stomach/abdominal area"), dental caries ("teeth deteriorate"), device expulsion ("one of the essure coils during one of her monthly cycles") and menorrhagia ("abnormal cycle and excessive bleeding") in a (b)(6) female patient who had essure (batch no.625646) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, menstrual cramps, endometrial ablation, implantable cardioverter defibrillator insertion in (b)(6) 2008, cardiac catheterisation in (b)(6) 2008, nulliparous and pain in hip.Previously administered products included for an unreported indication: cortisone.Concurrent conditions included heart disorder.Concomitant products included glyceryl trinitrate (nitroglycerin) since 2008 for angina pectoris, acetylsalicylic acid (aspirin) since 2008 for anticoagulant therapy, atorvastatin calcium (lipitor) since 2008 and ezetimibe (zetia) since 2008 for blood cholesterol abnormal, carvedilol (coreg) since 2008 for blood pressure abnormal, amiodarone (cordarone) since (b)(6) 2017 for cardiovascular disorder, furosemide (lasix) since 2008 for fluid retention, spironolactone (aldactone a) since 2008 for heart disorder, cholecalciferol (vitamin d3) since 2008 for hypovitaminosis d and lekovit ca (calcimagon) since 2016 for vitamin deficiency.In 2008, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required).On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced dental caries (seriousness criterion medically significant), fibromyalgia ("fibromyalgia"), anxiety ("anxiety"), depression ("depression"), neuropathy peripheral ("neuropathy"), scar ("scar tissue formed in my abdomen"), device expulsion (seriousness criteria medically significant and intervention required), impaired gastric emptying ("gastroparesis"), alopecia ("hair loss"), back pain ("worsening back pain"), migraine ("migraines/headaches") and headache ("migraines/headaches").The patient was treated with sertraline (zoloft), alprazolam (xanax), temazepam (restoril), buspirone hydrochloride (buspar), surgery (partial hysterectomy), surgery (all of my teeth removed/ oral medication) and surgery ((b)(6)).At the time of the report, the abdominal pain lower and dental caries had resolved, the fibromyalgia, neuropathy peripheral, scar, device expulsion, impaired gastric emptying, alopecia, back pain, migraine, headache and menorrhagia outcome was unknown and the anxiety and depression was resolving.The reporter considered abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, device expulsion, fibromyalgia, headache, impaired gastric emptying, menorrhagia, migraine, neuropathy peripheral and scar to be related to essure.Diagnostic results: on (b)(6) 2008, operative report at time of insertion: the tubal ostium on each side was found with a fair amount of difficulty because of the configuration of the uterus and the thickness of the endometrium.However, each ostium was ultimately found and cannulated with an essure device.The device was deployed, leaving a coil in place in the ostium.There was no significant bleeding.Current weight: (b)(6); approximate weight at the time of essure placement: (b)(6) (units unspecified).Essure confirmation test: (b)(6) 2008 hsg (hysterosalpingogram).Most recent follow-up information incorporated above includes: on 20-apr-2018: plaintiff fact sheet received case became incident.Events gastroparesis,back pain, migraines,headaches & menorrhagia are added.Event outcome updated.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ("lower abdomen cramping pain/severe and persistent cramping in my lower stomach/abdominal area"), dental caries ("teeth deteriorate") and menorrhagia ("abnormal cycle and excessive bleeding") in a 30-year-old female patient who had essure (batch no.625646) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device expulsion "one of the essure coils during one of her monthly cycles" (seriousness criteria medically significant and intervention required).The patient's medical history included depression, menstrual cramps, endometrial ablation, implantable cardioverter defibrillator insertion in (b)(6)2008, cardiac catheterisation in (b)(6)2008, nulliparous and pain in hip.Previously administered products included for an unreported indication: cortisone.Concurrent conditions included heart disorder.Concomitant products included glyceryl trinitrate (nitroglycerin) since 2008 for angina pectoris, acetylsalicylic acid (aspirin) since 2008 for anticoagulant therapy, atorvastatin calcium (lipitor) since 2008 and ezetimibe (zetia) since 2008 for blood cholesterol abnormal, carvedilol (coreg) since 2008 for blood pressure abnormal, amiodarone hydrochloride (cordarone) since (b)(6)2017 for cardiovascular disorder, furosemide (lasix) since 2008 for fluid retention, spironolactone (aldactone a) since 2008 for heart disorder, colecalciferol (vitamin d3) since 2008 for hypovitaminosis d and lekovit ca (calcimagon) since 2016 for vitamin deficiency.In 2008, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required).On (b)(6)2008, the patient had essure inserted.In (b)(6)2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced dental caries (seriousness criterion medically significant), fibromyalgia ("fibromyalgia"), anxiety ("anxiety"), depression ("depression"), neuropathy peripheral ("neuropathy"), scar ("scar tissue formed in my abdomen"), impaired gastric emptying ("gastroparesis"), alopecia ("hair loss"), back pain ("worsening back pain"), migraine ("migraines/headaches") and headache ("migraines/headaches").The patient was treated with alprazolam (xanax), buspirone hydrochloride (buspar), sertraline hydrochloride (zoloft), temazepam (restoril) and surgery (ablation and d&c, partial hysterectomy, partial hysterectomy.And all of my teeth removed/ oral medication).At the time of the report, the abdominal pain lower and dental caries had resolved, the fibromyalgia, neuropathy peripheral, scar, impaired gastric emptying, alopecia, back pain, migraine, headache and menorrhagia outcome was unknown and the anxiety and depression was resolving.The reporter considered abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, fibromyalgia, headache, impaired gastric emptying, menorrhagia, migraine, neuropathy peripheral and scar to be related to essure.Diagnostic results: on (b)(6)2008, operative report at time of insertion: the tubal ostium on each side was found with a fair amount of difficulty because of the configuration of the uterus and the thickness of the endometrium.However, each ostium was ultimately found and cannulated with an essure device.The device was deployed, leaving a coil in place in the ostium.There was no significant bleeding.*current weight: 213; approximate weight at the time of essure placement: 210 (units unspecified).Essure confirmation test: (b)(6)2008 hsg (hysterosalpingogram).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-jan-2019: quality-safety evaluation of product technical complaint.Incident: we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ("lower abdomen cramping pain/severe and persistent cramping in my lower stomach/abdominal area"), dental caries ("teeth deteriorate"), device expulsion ("one of the essure coils during one of her monthly cycles") and menorrhagia ("abnormal cycle and excessive bleeding") in a 30-year-old female patient who had essure (batch no.625646) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, menstrual cramps, endometrial ablation, implantable cardioverter defibrillator insertion in (b)(6) 2008, cardiac catheterisation in (b)(6) 2008, nulliparous and pain in hip.Previously administered products included for an unreported indication: cortisone.Concurrent conditions included heart disorder.Concomitant products included glyceryl trinitrate (nitroglycerin) since 2008 for angina pectoris, acetylsalicylic acid (aspirin) since 2008 for anticoagulant therapy, atorvastatin calcium (lipitor) since 2008 and ezetimibe (zetia) since 2008 for blood cholesterol abnormal, carvedilol (coreg) since 2008 for blood pressure abnormal, amiodarone (cordarone) since june 2017 for cardiovascular disorder, furosemide (lasix) since 2008 for fluid retention, spironolactone (aldactone a) since 2008 for heart disorder, colecalciferol (vitamin d3) since 2008 for hypovitaminosis d and lekovit ca (calcimagon) since 2016 for vitamin deficiency.In 2008, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required).On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced dental caries (seriousness criterion medically significant), fibromyalgia ("fibromyalgia"), anxiety ("anxiety"), depression ("depression"), neuropathy peripheral ("neuropathy"), scar ("scar tissue formed in my abdomen"), device expulsion (seriousness criteria medically significant and intervention required), impaired gastric emptying ("gastroparesis"), alopecia ("hair loss"), back pain ("worsening back pain"), migraine ("migraines/headaches") and headache ("migraines/headaches").The patient was treated with sertraline (zoloft), alprazolam (xanax), temazepam (restoril), buspirone hydrochloride (buspar), surgery (partial hysterectomy), surgery (all of my teeth removed/ oral medication), surgery (partial hysterectomy.) and surgery (ablation and d&c).At the time of the report, the abdominal pain lower and dental caries had resolved, the fibromyalgia, neuropathy peripheral, scar, device expulsion, impaired gastric emptying, alopecia, back pain, migraine, headache and menorrhagia outcome was unknown and the anxiety and depression was resolving.The reporter considered abdominal pain lower, alopecia, anxiety, back pain, dental caries, depression, device expulsion, fibromyalgia, headache, impaired gastric emptying, menorrhagia, migraine, neuropathy peripheral and scar to be related to essure.Diagnostic results: on (b)(6) 2008, operative report at time of insertion: the tubal ostium on each side was found with a fair amount of difficulty because of the configuration of the uterus and the thickness of the endometrium.However, each ostium was ultimately found and cannulated with an essure device.The device was deployed, leaving a coil in place in the ostium.There was no significant bleeding.*current weight: 213; approximate weight at the time of essure placement: (b)(4) units unspecified).Essure confirmation test: (b)(6) 2008 hsg (hysterosalpingogram).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: quality safety evaluation of ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('lower abdomen cramping pain/severe and persistent cramping in my lower stomach/abdominal area/cramping'), menorrhagia ('abnormal cycle and excessive bleeding'), device expulsion ('one of the essure coils during one of her monthly cycles'), genital haemorrhage ('abnormal bleeding and excessive bleeding') and dental caries ('teeth deteriorate/dental') in a 30-year-old female patient who had essure (batch no.625646) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "essure device guidewire got stuck in left fallopian tube after being deployed into tube".The patient's medical history included implantable cardioverter defibrillator insertion in (b)(6) 2008, cardiac catheterisation in (b)(6) 2008, depression, menstrual cramps, endometrial ablation, nulliparous, pain in hip, chronic cervicitis, hemorrhagic cyst, cardiomyopathy and palpitations.Previously administered products included for an unreported indication: cortisone.Concurrent conditions included heart disorder.Concomitant products included glyceryl trinitrate (nitroglycerin) since 2008 for angina pectoris, acetylsalicylic acid (aspirin) since 2008 for anticoagulant therapy, atorvastatin calcium (lipitor) since 2008 and ezetimibe (zetia) since 2008 for blood cholesterol abnormal, carvedilol (coreg) since 2008 for blood pressure abnormal, amiodarone hydrochloride (cordarone) since (b)(6) 2017 for cardiovascular disorder, furosemide (lasix) since 2008 for fluid retention, spironolactone (aldactone a) since 2008 for heart disorder, colecalciferol (vitamin d3) since 2008 for hypovitaminosis d and calcium carbonate;colecalciferol since 2016 for vitamin deficiency.In 2008, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required).On (b)(6) 2008, the patient had essure inserted.In 2009, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).In (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).In 2011, the patient experienced arthralgia ("right hip pain").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), dental caries (seriousness criterion medically significant), endometrial hyperplasia ("pre-cancerous cells"), fibromyalgia ("fibromyalgia"), anxiety ("anxiety"), depression ("depression"), neuropathy peripheral ("neuropathy"), scar ("scar tissue formed in my abdomen"), impaired gastric emptying ("gastroparesis"), alopecia ("hair loss"), back pain ("worsening back pain/back pain"), migraine ("migraines/headaches"), headache ("migraines/headaches"), abdominal distension ("bloating"), abdominal pain ("abdominal cramping") and abdominal pain upper ("stomach cramping").The patient was treated with alprazolam (xanax), buspirone hydrochloride (buspar), sertraline hydrochloride (zoloft), and surgery (ablation and d&c, partial hysterectomy., ablation and d and c after passing the first coil, all of my teeth removed/ oral medication/oral surgery and total abdominal hysterectomy, right salpingooophorectomy).At the time of the report, the abdominal pain lower, dental caries and abdominal pain had resolved, the menorrhagia, device expulsion, genital haemorrhage, endometrial hyperplasia, fibromyalgia, neuropathy peripheral, scar, impaired gastric emptying, alopecia, migraine, headache, abdominal distension and abdominal pain upper outcome was unknown, the anxiety and depression was resolving and the back pain and arthralgia had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, alopecia, anxiety, arthralgia, back pain, dental caries, depression, device expulsion, endometrial hyperplasia, fibromyalgia, genital haemorrhage, headache, impaired gastric emptying, menorrhagia, migraine, neuropathy peripheral and scar to be related to essure.The reporter commented: in (b)(6) 2009: 1 coils came out on its own.Diagnostic results: on (b)(6) 2008, operative report at time of insertion: the tubal ostium on each side was found with a fair amount of difficulty because of the configuration of the uterus and the thickness of the endometrium.However, each ostium was ultimately found and cannulated with an essure device.The device was deployed, leaving a coil in place in the ostium.There was no significant bleeding.*current weight: 213; approximate weight at the time of essure placement: 210 (units unspecified).Essure confirmation test: (b)(6) 2008 hsg (hysterosalpingogram).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-nov-2019: pfs received.Genital bleeding, bloating, abdominal cramping, stomach cramping, essure device guide wire got stuck in left fallopian tube after being deployed into tube, pre-cancerous cells were added.Incident: we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
