| Model Number ESS305 |
| Device Problems
Break (1069); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Cardiomyopathy (1764); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Pelvic Inflammatory Disease (2000); Rash (2033); Scarring (2061); Abnormal Vaginal Discharge (2123); Vomiting (2144); Abdominal Distention (2601); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2015 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("the essure breaking"), genital haemorrhage ("bleeding / severe bleeding") and cardiomyopathy ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 4 ((b)(6) 2008, (b)(6) 2009, (b)(6) 2011, (b)(6) 2013), appendicectomy in 2005, pre-eclampsia (pre-eclampsia with my third and fourth child.) and appendicectomy (appendix was inflamed) in 2005 and psychological disorder (psychological disorder nos).Previously administered products included for an unreported indication: mirena from 2011 to 2012 and yaz birth control pills from 2009 to 2010.Concomitant products included analgesics and antibiotics for pain relief and allergic reaction.In 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced headache ("headaches").In 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain, cardiomyopathy (seriousness criterion medically significant), dyspareunia ("pain during intercourse"), back pain ("back pain"), vomiting ("vomiting"), allergy to metals ("hypersensitivity reaction to nickel") with rash, dental caries ("tooth decay"), hormone level abnormal ("hormonal changes / because my hormones are little out of whack "), infection ("infections "), bladder disorder ("bladder issues"), urinary tract disorder ("urinary issues"), fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), adenomyosis ("sever adenomyosis"), scar ("post hysterectomy scars"), hypotrichosis ("minor facial hair"), acne ("breakouts on my neck"), mental disorder ("aggravated any psychiatric and/or psychological condition/ mentally it hurts that she was no longer a full women"), complication of device insertion ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few more hrs"), abdominal distension ("bloating"), investigation noncompliance ("did not undergo essure confirmation test"), ear infection ("ear infection"), migraine ("migraines"), gastrointestinal disorder ("bowel issues / bowels are screwed / bm are mucus and runny") with diarrhoea, gastroenteritis viral ("stomach flu or food poisioning"), feeling abnormal ("brain fog") and dysgeusia ("metallic taste").The patient was treated with surgery (hysterectomy (partial) left part of the cervix and overies).Essure was removed in (b)(6) 2015.At the time of the report, the device breakage, cardiomyopathy, allergy to metals, hormone level abnormal, infection, bladder disorder, urinary tract disorder, fatigue, vaginal discharge, scar, hypotrichosis, acne, mental disorder, complication of device insertion, investigation noncompliance, ear infection, migraine, gastrointestinal disorder and gastroenteritis viral outcome was unknown, the genital haemorrhage, dental caries and adenomyosis was resolving and the dyspareunia, back pain, vomiting, headache, abdominal distension, feeling abnormal and dysgeusia had resolved.The reporter considered abdominal distension, acne, adenomyosis, allergy to metals, back pain, bladder disorder, cardiomyopathy, complication of device insertion, dental caries, device breakage, dysgeusia, dyspareunia, ear infection, fatigue, feeling abnormal, gastroenteritis viral, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hypotrichosis, infection, investigation noncompliance, mental disorder, migraine, scar, urinary tract disorder, vaginal discharge and vomiting to be related to essure.The reporter commented: discrapancy noted in essure implant date ((b)(6)).She did not claime essure worsened a previously existing injury.She did not undergo an essure confirmation test.She used condoms; 6-8 months after the essure.She did not retain the essure or any portion of it.(severe cramping, constant bleeding, back pain, vomiting, runny stools, headaches, severe pain during intercourse, severe adenomyosis, the tooth decay has decreased; roughly 12-16 weeks after the removal of essure).She did not advised any complications from your essure removal procedure diagnostic results: (b)(6) 2015-ultrasoun scan (bloody and painful).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 confirm that all parts are accounted for and inspect the device 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.Final risk classification: risk category v.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse event is a known, possible, undesirable event 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: on 15-nov-2017: plaintiff fact sheet received.Events severe cramping, bleeding, pain during intercourse, back pain, vomiting, headaches, rash, tooth decay, hormonal changes, partial hysterectomy, infections, bladder/urinary issues, the essure breaking, fatigue, vaginal discharge, adenomyosis.Post hysterectomy, bloating, ear infection, and stomach flu added.Historical condition & drug, concomitant drug, product information updated.Reporter and patient information updated.¿essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (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¿ essure.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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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("the essure breaking"), genital haemorrhage ("bleeding / severe bleeding") and cardiomyopathy ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few") in an adult female patient who had essure 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 "did not undergo essure confirmation test".The patient's past medical history included multigravida, parity 4 ((b)(6) 2008, (b)(6) 2009, (b)(6) 2011, (b)(6) 2013), appendicectomy in 2005, pre-eclampsia (pre-eclampsia with my third and fourth child.), appendicectomy (appendix was inflamed) in 2005 and psychological disorder nos.Previously administered products included for an unreported indication: mirena from 2011 to 2012 and yaz birth control pills from 2009 to 2010.Concomitant products included analgesics and antibiotics for pain relief and allergic respiratory symptom.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced headache ("headaches").In 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain, cardiomyopathy (seriousness criterion medically significant), dyspareunia ("pain during intercourse"), back pain ("back pain"), vomiting ("vomiting"), allergy to metals ("hypersensitivity reaction to nickel") with rash, dental caries ("tooth decay"), hormone level abnormal ("hormonal changes / because my hormones are little out of whack "), infection ("infections"), bladder disorder ("bladder issues"), urinary tract disorder ("urinary issues"), fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), adenomyosis ("sever adenomyosis"), scar ("post hysterectomy scars"), hirsutism ("minor facial hair"), acne ("breakouts on my neck"), mental disorder ("aggravated any psychiatric and/or psychological condition/ mentally it hurts that she was no longer a full women"), complication of device insertion ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few more hrs"), abdominal distension ("bloating"), ear infection ("ear infection"), migraine ("migraines"), gastrointestinal disorder ("bowel issues / bowels are screwed / bm are mucus and runny") with diarrhoea, gastroenteritis viral ("stomach flu or food poisioning"), feeling abnormal ("brain fog"), dysgeusia ("metallic taste") and weight fluctuation ("weight fluctuation(11 pounds so far)").The patient was treated with surgery (hysterectomy (partial) left part of cervix and overies, bilateral salpingectomy, total hysterectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, cardiomyopathy, allergy to metals, hormone level abnormal, infection, bladder disorder, urinary tract disorder, fatigue, vaginal discharge, scar, hirsutism, acne, mental disorder, complication of device insertion, ear infection, migraine, gastrointestinal disorder, gastroenteritis viral and weight fluctuation outcome was unknown, the genital haemorrhage, dental caries and adenomyosis was resolving and the dyspareunia, back pain, vomiting, headache, abdominal distension, feeling abnormal and dysgeusia had resolved.The reporter considered abdominal distension, acne, adenomyosis, allergy to metals, back pain, bladder disorder, cardiomyopathy, complication of device insertion, dental caries, device breakage, dysgeusia, dyspareunia, ear infection, fatigue, feeling abnormal, gastroenteritis viral, gastrointestinal disorder, genital haemorrhage, headache, hirsutism, hormone level abnormal, infection, mental disorder, migraine, scar, urinary tract disorder, vaginal discharge, vomiting and weight fluctuation to be related to essure.The reporter commented: discrapancy noted in essure implant date ((b)(6) 2013 or (b)(6) 2013).She did not claime essure worsened a previously existing injury.She did not undergo an essure confirmation test.She used condoms; 6-8 months after the essure.She did not retain the essure or any portion of it.(severe cramping, constant bleeding, back pain, vomiting, runny stools, headaches, severe pain during intercourse, severe adenomyosis, the tooth decay has decreased; roughly 12-16 weeks after the removal of essure).She did not advised any complications from your essure removal procedure she reported 11 pounds so far -not understood , hence captured as event " weight fluctuation" diagnostic results: (b)(6) 2015-ultrasoun scan (bloody and painful).Concerning the injuries reported in this case, the following one were reported via social media: weight fluctuation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: plaintiff fact sheet received: reporters added.Event weight fluctuation 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 device breakage ("the essure breaking"), salpingitis ("salpingitis"), endometritis ("endometritis"), genital haemorrhage ("bleeding / severe bleeding") and cardiomyopathy ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few") in an adult female patient who had essure 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 "did not undergo essure confirmation test".The patient's medical history included multigravida, parity 4 (b)(6) -2008, (b)(6) -2009, (b)(6) 2011, (b)(6) 2013), appendicectomy in 2005, pre-eclampsia (pre-eclampsia with my third and fourth child.), appendicectomy (appendix was inflamed) in 2005, psychological disorder nos, metrorrhagia, uterine bleeding and ovarian cyst.Previously administered products included for an unreported indication: mirena from 2011 to 2012 and yaz birth control pills from 2009 to 2010.Concurrent conditions included genital irritation, vision blurred, menses irregular, pelvic pain, post procedural pain, frequency of menses, abdominal pain lower, diarrhea, nabothian cyst, dysmenorrhea, tiredness, overweight, vaginal discharge, bleeding menstrual heavy and nickel sensitivity.The patient also had a family history of nickel sensitivity.Concomitant products included analgesics and antibiotics for pain relief and allergic respiratory symptom as well as betacarotene;bioflavonoids;biotin;calcium ascorbate;calcium pantothenate;calcium phosphate;choline bitartrate;chromic chloride;colecalciferol;copper sulfate;cyanocobalamin;folic acid;hesperidin;inositol;iron amino acid chelate;lycopene;lysine hydrochloride;magnesium oxide;manganese sulfate;molybdenum trioxide;nicotinamide;phytomenadione;potassium iodide;potassium sulfate;pyridoxine hydrochloride;retinol acetate;riboflavin;selenomethionine;silicon dioxide, colloidal;sodium borate decahydrate;thiamine mononitrate;tocopheryl acid succinate;ubidecarenone;zinc oxide (multivitamin & mineral), docusate sodium, ibuprofen and tramadol.On (b)(6) 2013, the patient had essure inserted.In september 2013, the patient experienced headache ("headaches").In 2015, the patient experienced genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain, salpingitis (seriousness criteria medically significant and intervention required), endometritis (seriousness criteria medically significant and intervention required), cardiomyopathy (seriousness criterion medically significant), dyspareunia ("pain during intercourse"), back pain ("back pain"), vomiting ("vomiting"), allergy to metals ("hypersensitivity reaction to nickel") with rash, dental caries ("tooth decay"), infection ("infections"), bladder disorder ("bladder issues"), urinary tract disorder ("urinary issues"), fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), adenomyosis ("sever adenomyosis"), scar ("post hysterectomy scars"), hirsutism ("minor facial hair"), acne ("breakouts on my neck"), mental disorder ("aggravated any psychiatric and/or psychological condition/ mentally it hurts that she was no longer a full women"), complication of device insertion ("had a cardiomyopathy trigemeny that happened during the insert which made them keep me for a few more hrs"), abdominal distension ("bloating"), ear infection ("ear infection"), migraine ("migraines"), gastrointestinal disorder ("bowel issues / bowels are screwed / bm are mucus and runny") with diarrhoea, gastroenteritis viral ("stomach flu or food poisioning"), feeling abnormal ("brain fog"), dysgeusia ("metallic taste") and weight fluctuation ("weight fluctuation(11 pounds so far)") and was found to have hormone level abnormal ("hormonal changes / because my hormones are little out of whack ").The patient was treated with surgery (hysterectomy (partial) left part of cervix and overies, bilateral salpingectomy, total hysterectomy and laproscopic supracrvical hysterectomy/bilaterla salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, salpingitis, endometritis, cardiomyopathy, allergy to metals, hormone level abnormal, infection, bladder disorder, urinary tract disorder, fatigue, vaginal discharge, scar, hirsutism, acne, mental disorder, complication of device insertion, ear infection, migraine, gastrointestinal disorder, gastroenteritis viral and weight fluctuation outcome was unknown, the genital haemorrhage, dental caries and adenomyosis was resolving and the dyspareunia, back pain, vomiting, headache, abdominal distension, feeling abnormal and dysgeusia had resolved.The reporter considered abdominal distension, acne, adenomyosis, allergy to metals, back pain, bladder disorder, cardiomyopathy, complication of device insertion, dental caries, device breakage, dysgeusia, dyspareunia, ear infection, endometritis, fatigue, feeling abnormal, gastroenteritis viral, gastrointestinal disorder, genital haemorrhage, headache, hirsutism, hormone level abnormal, infection, mental disorder, migraine, salpingitis, scar, urinary tract disorder, vaginal discharge, vomiting and weight fluctuation to be related to essure.The reporter commented: discrapancy noted in essure implant date (aug-13 or sep-13).She did not claime essure worsened a previously existing injury.She did not undergo an essure confirmation test.She used condoms; 6-8 months after the essure.She did not retain the essure or any portion of it.(severe cramping, constant bleeding, back pain, vomiting, runny stools, headaches, severe pain during intercourse, severe adenomyosis, the tooth decay has decreased; roughly 12-16 weeks after the removal of essure).She did not advised any complications from your essure removal procedure she reported 11 pounds so far -not understood , hence captured as event " weight fluctuation" diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2015: specimen received as 'uterus, bilateral fallopian tubes': 75 gram fragmented portions of uterine corpus and fallopian tube exhibiting: -endometrium secretory endometrium.-myometrium with in normal limits.-fallopian tube portions, para tubal cysts.Diagnostic results: mar-2015-ultrasoun scan (bloody and painful) concerning the injuries reported in this case, the following one were reported via social media: weight fluctuation, rash, headaches, adenomyosis and dyspareunia.Concerning the injuries reported in this case, the following one were reported via medical records: endometritis and salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: mr received.Reporter information were added.Concomitant drug, medical history and lab data were added.Event : salpingitis and endometritis were added.Incident no lot number or device sample was received in this case.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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