| Model Number ESS305 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Diarrhea (1811); Fatigue (1849); Flatus (1865); Menstrual Irregularities (1959); Pain (1994); Positive antinuclear antibodies (ANA) (2015); Thyroid Problems (2102); Abdominal Distention (2601); Heavier Menses (2666); Foreign Body In Patient (2687); Test Result (2695)
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| Event Date 08/01/2017 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (fda, reference number: mw5076036) on 03-apr-2018.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("heavy bleeding in period") and autoimmune thyroiditis ("hashimotos") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included antidiarrhoeal microorganisms (probiotics), colecalciferol (vitamin d), levothyroxine, liothyronine sodium (cytomel), naltrexone and thyroid hormones.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria hospitalization, disability and intervention required), autoimmune thyroiditis (seriousness criterion medically significant), abdominal distension ("severe bloating"), amenorrhoea ("few years of no periods right after implants"), sciatica ("sciatica"), fatigue ("extreme fatigue"), hangover ("feeling of being hung over without drinking alcohol"), blood heavy metal increased ("extremely high levels of heavy metals"), gastrointestinal disorder ("gi issues"), diarrhoea ("diarrhea"), food allergy ("many food sensitivities"), oral lichen planus ("oral lichen planus"), hepatic enzyme increased ("liver enzymes were high"), white blood cell count decreased ("white blood counts were low"), hormone level abnormal ("extremely low hormone levels"), pain ("body aches"), exercise tolerance decreased ("no endurance") and antinuclear antibody (b)(6) ("tested high for the lupus antibody, ana").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, autoimmune thyroiditis, abdominal distension, amenorrhoea, sciatica, fatigue, hangover, blood heavy metal increased, gastrointestinal disorder, diarrhoea, food allergy, oral lichen planus, hepatic enzyme increased, white blood cell count decreased, hormone level abnormal, pain, exercise tolerance decreased and antinuclear antibody (b)(6) outcome was unknown.The reporter considered abdominal distension, amenorrhoea, antinuclear antibody (b)(6), autoimmune thyroiditis, blood heavy metal increased, diarrhoea, exercise tolerance decreased, fatigue, food allergy, gastrointestinal disorder, hangover, hepatic enzyme increased, hormone level abnormal, menorrhagia, oral lichen planus, pain, sciatica and white blood cell count decreased to be related to essure.The reporter commented: injuries (disability/permanent damage and hospitalization) were mentioned but not specified and /or assigned to one of the events.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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Case was initially received via regulatory authority (fda, reference number: mw5076036) on 03-apr-2018.The most recent information was received on 12-sep-2018.This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ("heavy bleeding in period") and autoimmune thyroiditis ("hashimotos") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included antidiarrhoeal microorganisms (probiotics), colecalciferol (vitamin d), levothyroxine, liothyronine sodium (cytomel), naltrexone and thyroid hormones.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria hospitalization, disability and intervention required), autoimmune thyroiditis (seriousness criterion medically significant), abdominal distension ("severe bloating"), amenorrhoea ("few years of no periods right after implants"), sciatica ("sciatica"), fatigue ("extreme fatigue"), hangover ("feeling of being hung over without drinking alcohol"), blood heavy metal increased ("extremely high levels of heavy metals"), gastrointestinal disorder ("gi issues"), diarrhoea ("diarrhea"), food allergy ("many food sensitivities"), oral lichen planus ("oral lichen planus"), hepatic enzyme increased ("liver enzymes were high"), white blood cell count decreased ("whit blood counts were low"), hormone level abnormal ("extremely low hormone levels"), pain ("body aches"), exercise tolerance decreased ("no endurance") and antinuclear antibody positive ("tested high for the lupus antibody, ana").The patient was treated with surgery (hysterectomy with essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, autoimmune thyroiditis, abdominal distension, amenorrhoea, sciatica, fatigue, hangover, blood heavy metal increased, gastrointestinal disorder, diarrhoea, food allergy, oral lichen planus, hepatic enzyme increased, white blood cell count decreased, hormone level abnormal, pain, exercise tolerance decreased and antinuclear antibody positive outcome was unknown.The reporter considered abdominal distension, amenorrhoea, antinuclear antibody positive, autoimmune thyroiditis, blood heavy metal increased, diarrhoea, exercise tolerance decreased, fatigue, food allergy, gastrointestinal disorder, hangover, hepatic enzyme increased, hormone level abnormal, menorrhagia, oral lichen planus, pain, sciatica and white blood cell count decreased to be related to essure.The reporter commented: injuries (disability/permanent damage and hospitalization) were mentioned but not specified and /or assigned to one of the events.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-sep-2018: quality safety evaluation of ptc.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 device expulsion ("1 in right tubal as/endometrium / one essure coil begins at the tubal 03 and extends to within theendometrial cavity"), menorrhagia ("heavy bleeding in period / abnormal bleeding (menorrhagia)") and autoimmune thyroiditis ("hashimotos") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included breast pain, augmentation mammoplasty, absence of menstruation, hypothyroidism, vitamin d deficiency and irregular periods.Previously administered products included for prevent pregnancy: iud from 2006 to (b)(6) 2009, iud in 2006 and birth control pill from 2004 to 2006.Past adverse reactions to the above products included device expulsion with iud.Concurrent conditions included body mass index normal, vitamin d deficiency, abdominal pain, chronic cervicitis, paratubal cyst and dysuria.Concomitant products included ethinylestradiol;ferrous fumarate;norethisterone acetate (lo loestrin fe) (b)(6) 2012 to 2013 for amenorrhea, probiotics [umbrella term] for weight gain, bloating and stools abnormal as well as alpha-amylase swine pancreas;cellulase;lipase;protease (digestive enzyme) since 2012, ascorbic acid;cobalt sulfate;copper sulfate;ergocalciferol;ferrous fumarate;magnesium sulfate;manganese sulfate;nicotinamide;potassium iodide;pyridoxine hydrochloride;retinol;riboflavin;thiamine hydrochloride;tocopherol;vitamin b12 nos;zinc gluconate (multivitamin (16)) from 2010 to 2012, calcium carbonate;vitamin d nos (calcium + vit d) from 2011 to 2013, cyanocobalamin from 2012 to 2014, doxycycline from (b)(6) 2013 to (b)(6) 2013, ferrous sulfate from 2012 to 2014, fish oil from 2012 to 2014, glutathione from 2012 to 2014, levothyroxine, levothyroxine;liothyronine (np thyroid) since (b)(6) 2017, liothyronine sodium (cytomel), liothyronine since (b)(6) 2017, naltrexone since (b)(6) 2012, thyroid (armour thyroid) from 2011 to 2012, thyroid (nature throid) from (b)(6) 2012 to (b)(6) 2017, thyroid hormones, ubidecarenone (co q-10) from 2012 to 2014 and vitamin d nos (vitamin d).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced fatigue ("extreme fatigue / fatigue") and asthenia ("lack of energy") and was found to have white blood cell count decreased ("white whit blood counts were low / infection (other) describe: low white blood count for a few years (it is normal now)").In (b)(6) 2009, the patient was found to have weight increased ("weight gain / loss specify which one:weight gain").In (b)(6) 2010, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant), allergy to metals ("nickel allergy"), nocturia ("bladder problems or changes very frequent urination, especially at night"), haematuria ("urinary problems or changes hematuria"), amnesia ("neurological conditions or problems type: memory loss"), candida infection ("autoimmune disorder type of disorder: candida"), erythema ("red spots all over back") and feeling abnormal ("brain fog") and was found to have blood heavy metal increased ("extremely high levels of heavy metals / allergic or hypersensitivity reaction type: diagnosed with extremely high heavy metal levels").In (b)(6) 2010, the patient experienced oral lichen planus ("oral lichen planus /autoimmune disorder type of disorder: oral lichen planus") with oral pain.In (b)(6) 2017, the patient experienced menorrhagia (seriousness criteria hospitalization, disability and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), abdominal distension ("severe bloating / gastrointestinal or digestive system condition type: very frequent bloating"), amenorrhoea ("few years of no periods right after implants"), sciatica ("sciatica"), hangover ("feeling of being hung over without drinking alcohol"), gastrointestinal disorder ("gi issues"), diarrhoea ("diarrhea"), food allergy ("many food sensitivities / gastrointestinal or digestive system condition type: food sensitivities"), pain ("body aches"), exercise tolerance decreased ("no endurance"), pelvic pain ("pain"), abnormal faeces ("gastrointestinal or digestive system condition type: issues with stools"), rash ("rashes on back") and pyrexia ("fever") and was found to have hepatic enzyme increased ("liver enzymes were high"), hormone level abnormal ("extremely low hormone levels") and antinuclear antibody positive ("tested high for the lupus antibody, ana").The patient was treated with nystatin and surgery (hysterectomy with essure removal, bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, autoimmune thyroiditis, amenorrhoea, sciatica, fatigue, hangover, blood heavy metal increased, gastrointestinal disorder, diarrhoea, food allergy, hepatic enzyme increased, white blood cell count decreased, hormone level abnormal, pain, exercise tolerance decreased, antinuclear antibody positive, vaginal haemorrhage, allergy to metals, nocturia, haematuria, pelvic pain, weight increased, candida infection, erythema and pyrexia outcome was unknown, the menorrhagia, abdominal distension, oral lichen planus, abnormal faeces and rash had resolved and the amnesia, asthenia and feeling abnormal was resolving.The reporter considered abdominal distension, abnormal faeces, allergy to metals, amenorrhoea, amnesia, antinuclear antibody positive, asthenia, autoimmune thyroiditis, blood heavy metal increased, candida infection, device expulsion, diarrhoea, erythema, exercise tolerance decreased, fatigue, feeling abnormal, food allergy, gastrointestinal disorder, haematuria, hangover, hepatic enzyme increased, hormone level abnormal, menorrhagia, nocturia, oral lichen planus, pain, pelvic pain, pyrexia, rash, sciatica, vaginal haemorrhage, weight increased and white blood cell count decreased to be related to essure.The reporter commented: injuries (disability/permanent damage and hospitalization) were mentioned but not specified and /or assigned to one of the events.If you had your essure removed, did you retain the essure device or any portion of it? yes if yes, identify where the removed essure device is being retained: removal healthcare facility.Current height 5 ft.7 in.Current weight 140 lbs.Bilateral essure coils (1 in right tube, 1 in left tube, 1 in right tubal as/endometrium.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: pelvic pain, menorrhagia, hematuria, amenorrhea, abdominal distension, weight gain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-jan-2019: pfs and mr were received: events: vaginal hemorrhage, memory loss, nickel allergy, pelvic pain, weight gain, bloating, stool problems, fever, cadida infection, dysuria, hematuria, erythema, asthenia, brain fog, mouth pain, rash, device expulsion were added.Event onset date and outcome were added.Concomitant drugs and historical drugs were added.Concomitant conditions were added.Lab data were added.Incident no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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