| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Reaction (1733); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Thyroid Problems (2102); Visual Impairment (2138); Tingling (2171); Anxiety (2328); Arthralgia (2355); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Abdominal Distention (2601); Intermenstrual Bleeding (2665)
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| Event Date 11/01/2014 |
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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: mw5043017) on (b)(6) 2015.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 ("severe pelvic pain") and autoimmune thyroiditis ("hashimoto's disease") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Concomitant products included ascorbic acid (vitamin c), cholecalciferol (vitamin d) and vitamin-b-complex standard (b complex).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced rash ("rash that went up my neck and across my face"), headache ("increased number of and severity of headaches"), back pain ("back aches"), pain ("body aches"), abdominal distension ("bloating"), nausea ("nausea"), abdominal pain ("abdominal pain after meals") and menometrorrhagia ("heavy period every 15 days; lasting for 6-7 days").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune thyroiditis (seriousness criterion disability) with dizziness, weight increased, fatigue, mood altered, hypertension, heart rate increased, cardiac disorder, blood thyroid stimulating hormone increased, alopecia, anxiety, depression, madarosis, pain of skin, arthralgia, insomnia, paraesthesia, memory impairment, aphasia, visual impairment, feeling abnormal and emotional distress, dysmenorrhoea ("pain during period was insurmountable"), pruritus ("severe itching"), autoimmune disorder ("autoimmune disorder/autoimmune reaction") and menstrual disorder ("persistent menstruation issues").The patient was treated with surgery (total hysterectomy due to complications from the essure device).At the time of the report, the pelvic pain, autoimmune thyroiditis, rash, headache, back pain, pain, abdominal distension, nausea, abdominal pain, menometrorrhagia, dysmenorrhoea, pruritus and outcome was unknown and menstrual disorder was not resolved.The reporter considered abdominal distension, abdominal pain, autoimmune disorder, autoimmune thyroiditis, back pain, dysmenorrhoea, headache, menometrorrhagia, menstrual disorder, nausea, pain, pelvic pain, pruritus and rash to be related to essure.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 this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known possible undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: summon received.Lawyers were added as reporter.Reporter information was updated.Case upgraded to incident category.Event: severe pelvic pain, persistent menstruation issues were added.Event:autoimmune disorder/autoimmune reaction were clubbed together.Essure was implanted on (b)(6) 2014 (previously reported as (b)(6) 2014).Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer (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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This case was initially received via regulatory authority (food and drug administration, reference number: mw5043017) on 20-jul-2015.The most recent information was received on 28-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), autoimmune thyroiditis ("hashimoto's disease/ hashimoto's thyroid disease"), autoimmune disorder ("autoimmune disorder/autoimmune reaction") and systemic lupus erythematosus ("lupus") in a 27-year-old female patient who had essure (batch no.B82477) 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 undergo an essure confirmation test".Concomitant products included ascorbic acid (vitamin c), colecalciferol (vitamin d) and vitamin-b-komplex standard (b complex).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced rash ("rash that went up my neck and across my face"), headache ("increased number of and severity of headaches"), back pain ("back aches"), pain ("body aches"), abdominal distension ("bloating"), nausea ("nausea"), abdominal pain ("abdominal pain after meals") and menometrorrhagia ("heavy period every 15 days; lasting for 6-7 days").On (b)(6) 2015, 1 year 1 month after insertion of essure, the patient experienced autoimmune thyroiditis (seriousness criterion disability) with dizziness, weight increased, fatigue, mood altered, hypertension, heart rate increased, cardiac disorder, blood thyroid stimulating hormone increased, alopecia, anxiety, depression, madarosis, pain of skin, arthralgia, insomnia, paraesthesia, memory impairment, aphasia, visual impairment, feeling abnormal and emotional distress.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), systemic lupus erythematosus (seriousness criterion medically significant), dysmenorrhoea ("pain during period was insurmountable"), pruritus ("severe itching"), menstrual disorder ("persistent menstruation issues"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, autoimmune thyroiditis, systemic lupus erythematosus, rash, headache, back pain, pain, abdominal distension, nausea, abdominal pain, menometrorrhagia, dysmenorrhoea, pruritus, vaginal haemorrhage and menorrhagia outcome was unknown and the menstrual disorder had not resolved.The reporter considered abdominal distension, abdominal pain, autoimmune disorder, autoimmune thyroiditis, back pain, dysmenorrhoea, headache, menometrorrhagia, menorrhagia, menstrual disorder, nausea, pain, pelvic pain, pruritus, rash, systemic lupus erythematosus and vaginal haemorrhage to be related to essure.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received.Reporter information, patient¿s demographic information updated.Essure lot number and removal date (b)(6) 2015 was added.Events hashimoto's thyroid disease was clubbed with previously reported event.Events vaginal bleeding, menorrhagia, systemic lupus erythematosus were newly 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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E was initially received via regulatory authority (food and drug administration, reference number: mw (b)(4)) on 20-jul-2015.The most recent information was received on 28-aug-2018.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), autoimmune thyroiditis ("autoimmune disorder/autoimmune reaction:hashimoto's disease") and systemic lupus erythematosus ("lupus") in a 27-year-old female patient who had essure (batch no.B82477) 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 undergo an essure confirmation test".The patient's past medical history included pregnancy, gestational hypertension, vaginal delivery and postpartum state.Concurrent conditions included menstruation irregular and adenomyosis.Concomitant products included ascorbic acid (vitamin c), colecalciferol (vitamin d) and vitamin-b-komplex standard (b complex).On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("pain during period was insurmountable"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2014, the patient experienced rash ("rash that went up my neck and across my face"), headache ("increased number of and severity of headaches"), back pain ("back aches"), pain ("body aches"), abdominal distension ("bloating"), nausea ("nausea"), abdominal pain ("abdominal pain after meals") and menometrorrhagia ("heavy period every 15 days; lasting for 6-7 days").In 2015, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant) with dizziness, weight increased, fatigue, mood altered, hypertension, heart rate increased, cardiac disorder, blood thyroid stimulating hormone increased, alopecia, anxiety, depression, madarosis, pain of skin, arthralgia, insomnia, paraesthesia, memory impairment, aphasia, visual impairment, feeling abnormal and emotional distress and dyspareunia ("dyspareunia ( painful sexual intercourse)").On an unknown date, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), pruritus ("severe itching") and menstrual disorder ("persistent menstruation issues").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain was resolving, the autoimmune thyroiditis, systemic lupus erythematosus, rash, headache, back pain, pain, abdominal distension, nausea, abdominal pain, menometrorrhagia, dysmenorrhoea, pruritus, vaginal haemorrhage, menorrhagia and dyspareunia outcome was unknown and the menstrual disorder had not resolved.The reporter considered abdominal distension, abdominal pain, autoimmune thyroiditis, back pain, dysmenorrhoea, dyspareunia, headache, menometrorrhagia, menorrhagia, menstrual disorder, nausea, pain, pelvic pain, pruritus, rash, systemic lupus erythematosus and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on (b)(6) 2014: negative.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2018: quality-safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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E was initially received via regulatory authority (food and drug administration, reference number: mw (b)(4)) on 20-jul-2015.The most recent information was received on 03-jul-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), autoimmune thyroiditis ("autoimmune disorder/autoimmune reaction:hashimoto's disease") and systemic lupus erythematosus ("lupus") in a 27-year-old female patient who had essure (batch no.B82477) 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 undergo an essure confirmation test".The patient's past medical history included pregnancy, gestational hypertension, vaginal delivery and postpartum state.Concurrent conditions included menstruation irregular and adenomyosis.Concomitant products included ascorbic acid (vitamin c), colecalciferol (vitamin d) and vitamin-b-komplex standard (b complex).On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("pain during period was insurmountable"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2014, the patient experienced rash ("rash that went up my neck and across my face"), headache ("increased number of and severity of headaches"), back pain ("back aches"), pain ("body aches"), abdominal distension ("bloating"), nausea ("nausea"), abdominal pain ("abdominal pain after meals") and menometrorrhagia ("heavy period every 15 days; lasting for 6-7 days").In 2015, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant) with dizziness, weight increased, fatigue, mood altered, hypertension, heart rate increased, cardiac disorder, blood thyroid stimulating hormone increased, alopecia, anxiety, depression, madarosis, pain of skin, arthralgia, insomnia, paraesthesia, memory impairment, aphasia, visual impairment, feeling abnormal and emotional distress and dyspareunia ("dyspareunia ( painful sexual intercourse)").On an unknown date, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), pruritus ("severe itching") and menstrual disorder ("persistent menstruation issues").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain was resolving, the autoimmune thyroiditis, systemic lupus erythematosus, rash, headache, back pain, pain, abdominal distension, nausea, abdominal pain, menometrorrhagia, dysmenorrhoea, pruritus, vaginal haemorrhage, menorrhagia and dyspareunia outcome was unknown and the menstrual disorder had not resolved.The reporter considered abdominal distension, abdominal pain, autoimmune thyroiditis, back pain, dysmenorrhoea, dyspareunia, headache, menometrorrhagia, menorrhagia, menstrual disorder, nausea, pain, pelvic pain, pruritus, rash, systemic lupus erythematosus and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on (b)(6) 2014: negative.Most recent follow-up information incorporated above includes: on 3-jul-2018: pfs received, demographic added, event dyspareunia added, events onset date updated, events outcome 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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This case was initially received via regulatory authority (food and drug administration, reference number: mw5043017) on 20-jul-2015.The most recent information was received on 07-jan-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/ pelvic pain"), autoimmune thyroiditis ("autoimmune disorder/autoimmune reaction: hashimoto's disease/ hashimoto's thyroid disease") and systemic lupus erythematosus ("lupus") in a 27-year-old female patient who had essure (batch no.B82477) 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 undergo an essure confirmation test".The patient's medical history included pregnancy, gestational hypertension, vaginal delivery and postpartum state.Previously administered products included for birth control: micronor.Concurrent conditions included menstruation irregular and adenomyosis.Concomitant products included ascorbic acid, ascorbic acid; calcium gluconate; cupric carbonate, basic; cyanocobalamin; ergocalciferol; ferrous sulfate; manganese chloride; nicotinamide; potassium iodide; pyridoxine hydrochloride; retinol; riboflavin; thiamine (prenatal), hydrocodone bitartrate; ibuprofen (vicoprofen), levothyroxine sodium (synthroid), multivitamin, norethisterone (micronor), ondansetron (zofran), oxycodone hydrochloride; paracetamol (percocet), vitamin b12 nos, vitamin d nos (vitamin d) and vitamin-b-komplex standard (b complex).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced rash ("rash that went up my neck and across my face"), headache ("increased number of and severity of headaches"), back pain ("back aches"), pain ("body aches"), abdominal distension ("bloating"), nausea ("nausea"), abdominal pain ("abdominal pain after meals") and menometrorrhagia ("heavy period every 15 days; lasting for 6-7 days").On (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune thyroiditis (seriousness criterion medically significant) with dizziness, weight increased, fatigue, mood altered, hypertension, heart rate increased, cardiac disorder, blood thyroid stimulating hormone increased, alopecia, anxiety, depression, madarosis, pain of skin, arthralgia, insomnia, paraesthesia, memory impairment, aphasia, visual impairment, feeling abnormal and emotional distress, dysmenorrhoea ("pain during period was insurmountable/ dysmenorrhoea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and dyspareunia ("dyspareunia ( painful sexual intercourse)"), 5 months 12 days after insertion of essure.On an unknown date, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), pruritus ("severe itching") and menstrual disorder ("persistent menstruation issues").The patient was treated with surgery (hysterectomy full with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, vaginal haemorrhage and menorrhagia had resolved, the autoimmune thyroiditis, systemic lupus erythematosus, rash, headache, back pain, pain, abdominal distension, nausea, abdominal pain, menometrorrhagia, dysmenorrhoea, pruritus and dyspareunia outcome was unknown and the menstrual disorder had not resolved.The reporter considered abdominal distension, abdominal pain, autoimmune thyroiditis, back pain, dysmenorrhoea, dyspareunia, headache, menometrorrhagia, menorrhagia, menstrual disorder, nausea, pain, pelvic pain, pruritus, rash, systemic lupus erythematosus and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test urine - on (b)(6) 2014: results: negative.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-jan-2019: pfs received.Reporter's information was added.Updated onset date of event (pain, bleeding).Historical drug was added.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.
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