| Model Number ESS305 |
| Device Problem
Appropriate Term/Code Not Available (3191)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Chest Pain (1776); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Abnormal Vaginal Discharge (2123); Vertigo (2134); Visual Impairment (2138); Vomiting (2144); Burning Sensation (2146); Hot Flashes/Flushes (2153); Chills (2191); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Malaise (2359); Respiratory Tract Infection (2420); Neck Pain (2433); Palpitations (2467); Sleep Dysfunction (2517); Abdominal Cramps (2543); Abdominal Distention (2601); Heavier Menses (2666)
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| Event Date 11/01/2013 |
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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 pelvic pain ("severe pelvic pain (intense burning hot/cold pain in my tubes where my coils were, like they were "on fire)/ cramps in the pelvic area (horrible cramping in my tubes and pelvic area)"), genital haemorrhage ("heavy bleeding/blood clots"), autoimmune disorder ("issues with autoimmune responses"), neuromyopathy (¿neuromyopathy¿), intra-abdominal haemorrhage (¿suspected postoperative intraabdominal bleed ¿) and rectal haemorrhage in a (b)(6) female patient who had essure (batch no.B42242) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3 ((b)(6) 2007, (b)(6) 2009 and (b)(6) 2013), prenatal care.Family history included menorrhagia (mother), osteoporosis (mother), hypertensive (grandmother), hypercholesterolemia (father), hyperlipidemia (father), thyroid disorder (grandmother), high blood pressure (father) concomitant products included atomoxetine hydrochloride (strattera) on (b)(6) 2012 for adhd, citalopram hydrobromide (celexa) on (b)(6) 2012 for anxiety and depression, gabapentin on (b)(6) 2014 for neuromyopathy, fluconazole (diflucan) on (b)(6) 2012 for vaginal discharge, flonase for allergic rhinitis, zyrtec for allergic rhinitis, azithromycin, benzonatate, fluticasone and tramadol.Historical drug included micronor.Concurrent condition included dysfunctional uterine bleeding.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), neck pain ("severe neck pain") and back pain ("severe back pain").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), the first episode of menorrhagia ("continuous periods/ heavy/abnormal menstrual cycles"), vaginal discharge ("yellow, runny discharge came out of my vagina"), burning sensation ("the burning"), uterine cervical pain ("pain in the cervix (cervix was constantly "on fire")/stabbing pains in cervix"), pruritus ("itchy"), vulvovaginal pain ("stabbing pains in vaginal"), dyspareunia ("pain during intercourse "), coital bleeding ("bleed during and after sex"), rectal haemorrhage ("bleeding from the rectum and in fecal matter"), abdominal distension ("bloating (belly was always bloated and swollen)"), swelling ("swelling"), rash pruritic ("developed a rash on my belly that itched"), acne ("acne/aching"), vomiting ("vomiting"), dental caries ("tooth decay"), nausea ("still have issues with nausea"), gastric disorder ("other gastro issues"), fibromyalgia ("fibromyalgia"), migraine ("severe migraines"), headache ("head pain"), plantar fasciitis ("plantar fascitis"), adverse reaction ("adverse reactions to eating certain foods"), allergy to metals ("hypersensitivity reaction to nickel"), mental disorder ("caused or aggravated psychiatric and/or psychological condition"), attention deficit/hyperactivity disorder, anxiety, dysgeusia, decreased appetite, fatigue, upper respiratory tract infection, sinusitis, rhinitis allergic, malaise, influenza, pain, thinking abnormal, anal incontinence, urinary incontinence, diarrhoea, visual impairment, sinus pain, sneezing, rhinorrhoea, pharyngeal oedema, tonsillar hypertrophy, burn oral cavity, throat irritation, burning sensation, asthenia, arthralgia, myalgia, muscle tightness, musculoskeletal stiffness, joint stiffness, abdominal pain lower, paraesthesia, hypoaesthesia, sciatica, intra-abdominal haemorrhage, rhinitis allergic, irritable bowel syndrome, discomfort, pyrexia, hot flush, chills, stress, gastrointestinal injury, flatulence, gastrooesophageal reflux disease, dyspepsia, restless legs syndrome, dysstasia, pain in extremity, muscular weakness, feeling abnormal, mood swings, irritability, dysuria, urinary retention, neuromyopathy, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, hypertonic bladder, bladder pain, muscle spasms, neuralgia, chest pain, insomnia, palpitations, vertigo, spinal osteoarthritis, visual impairment, dysphagia, confusional state, disorientation, memory impairment, cervical radiculopathy, back disorder, joint dislocation, chest discomfort, dizziness, dyspnoea, alopecia, night sweats, loss of libido, weight decreased, gastrooesophageal reflux disease, dyspepsia, cough, allergy to metals, uterine enlargement, gastrointestinal pain, anaemia postoperative, adverse reaction.The patient was treated with surgery (total hysterectomy and bilateral salpingectomy, cystoscopy.).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, neck pain , fibromyalgia, influenza, adverse reaction, irritable bowel syndrome and back pain had not resolved.Patient was resolved with the events attention deficit/hyperactivity disorder, anxiety, dysgeusia, decreased appetite, fatigue, upper respiratory tract infection, sinusitis, rhinitis allergic, malaise, influenza, pain, thinking abnormal, anal incontinence, urinary incontinence, diarrhoea, visual impairment, sinus pain, sneezing, rhinorrhoea, pharyngeal oedema, tonsillar hypertrophy, burn oral cavity, throat irritation, burning sensation, asthenia, arthralgia, myalgia, muscle tightness, musculoskeletal stiffness, joint stiffness, abdominal pain lower, paraesthesia, hypoaesthesia, sciatica, intra-abdominal haemorrhage, rhinitis allergic, irritable bowel syndrome and outcome of events discomfort, pyrexia, hot flush, chills, stress, gastrointestinal injury, flatulence, gastrooesophageal reflux disease, dyspepsia, restless legs syndrome, dysstasia, pain in extremity, muscular weakness, feeling abnormal, mood swings, irritability, dysuria, urinary retention, neuromyopathy, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, hypertonic bladder, bladder pain, muscle spasms, neuralgia, chest pain, insomnia, palpitations, vertigo, spinal osteoarthritis, visual impairment, dysphagia, confusional state, disorientation, memory impairment, cervical radiculopathy, back disorder, joint dislocation, chest discomfort, dizziness, dyspnoea, alopecia, night sweats, loss of libido, weight decreased, gastrooesophageal reflux disease, dyspepsia, cough, allergy to metals, uterine enlargement, gastrointestinal pain, anaemia postoperative was unknown.The reporter considered abdominal distension, acne, adverse reaction, allergy to metals, autoimmune disorder, back pain, burning sensation, coital bleeding, dental caries, dyspareunia, fibromyalgia, gastric disorder, genital haemorrhage, headache, mental disorder, migraine, nausea, neck pain, pelvic pain, plantar fasciitis, pruritus, rash pruritic, rectal haemorrhage, swelling, uterine cervical pain, vaginal discharge, vomiting, vulvovaginal pain, attention deficit/hyperactivity disorder, anxiety, dysgeusia, decreased appetite, fatigue, upper respiratory tract infection, sinusitis, rhinitis allergic, malaise, influenza, pain, thinking abnormal, anal incontinence, urinary incontinence, diarrhoea, visual impairment, sinus pain, sneezing, rhinorrhoea, pharyngeal oedema, tonsillar hypertrophy, burn oral cavity, throat irritation, burning sensation, asthenia, arthralgia, myalgia, muscle tightness, musculoskeletal stiffness, joint stiffness, abdominal pain lower, paraesthesia, hypoaesthesia, sciatica, intra-abdominal haemorrhage, rhinitis allergic, irritable bowel syndrome, discomfort, pyrexia, hot flush, chills, stress, gastrointestinal injury, flatulence, gastrooesophageal reflux disease, dyspepsia, restless legs syndrome, dysstasia, pain in extremity, muscular weakness, feeling abnormal, mood swings, irritability, dysuria, urinary retention, neuromyopathy, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, hypertonic bladder, bladder pain, muscle spasms, neuralgia, chest pain, insomnia, palpitations, vertigo, spinal osteoarthritis, visual impairment, dysphagia, confusional state, disorientation, memory impairment, cervical radiculopathy, back disorder, joint dislocation, chest discomfort, dizziness, dyspnoea, alopecia, night sweats, loss of libido, weight decreased, gastrooesophageal reflux disease, dyspepsia, cough, allergy to metals, uterine enlargement, gastrointestinal pain, anaemia postoperative the first episode of menorrhagia and the second episode of menorrhagia to be related to essure.The reporter commented: pfs-she had lost 1,000 cc of blood.He did a fulguration of the bleeding vessel and an evacuation of hemoperitoneum.Mr-number of coils remaining out on the: right side-3, left side-4.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: essure confirmation test.On (b)(6) 2014, abdominal ct scan was done due to pelvic pain.On (b)(6) 2015, ultrasound of gallbladder was done due to abdominal pain.On (b)(6) 2015, trans-vaginal ultrasound was done due to pelvic pain.On (b)(6) 2014, hysterosalpingogram-findings: essure micro-inserts are identified in the proximal fallopian tubes bilaterally, and appear appropriately located.Impression: bilateral obstructed fallopian tube status post essure procedure.On (b)(6) 2014, hcg- negative.On (b)(6) 2014, hcg test- negative.On (b)(6) 2014, tissue report-final diagnosis: uterus (90 grams) with bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: benign proliferative endometrium benign fallopian tubes with a right simple paratubal cyst present and ct abdomen pelvis (b)(6) 2014 impression: postoperative pneumoperitoneum.Postoperative subcutaneous emphysema ct pelvic impression: postoperative pneumoperitoneum.Postoperative subcutaneous emphysema and ct pelvic- impression: postop hysterectomy.Minimal pelvic ascites.On (b)(6) 2017, mri cervical spine without contrast- findings: minimal degenerative changes in the cervical spine, there is minimal posterior disk bulge a c4-5, c5-6 and c6-7, small central annular fissure at cs-6, no central canal or neural foraminal stenosis.Impression: minimal degenerative changes as described above.No evidence of central canal or neural foraminal stenosis.Normal cord signal.Most recent follow-up information incorporated above includes: on (b)(6) 2017: plaintiff fact sheet and medical record received.Relevant medical history, concurrent condition/ medication, historical drug and lab test were added.Indication and lot number (b42242) was added.Case was upgraded to incident.Event injury nos was deleted and following serious events added: pelvic pain, genital haemorrhage, autoimmune disorder, neuromyopathy, intra-abdominal haemorrhage and rectal haemorrhage.Additional non serious events were also added.Essure legal manufacture has changed from bayer healthcare, llc, (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.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain (intense burning hot/cold pain in my tubes where my coils were, like they were "on fire)/ cramps in the pelvic area (horrible cramping in my tubes and pelvic area)/ severe and persistent pain/chronic pain"), genital haemorrhage ("heavy bleeding/blood clots"), autoimmune disorder ("issues with autoimmune responses"), neuromyopathy ("neuromyopathy"), intra-abdominal haemorrhage ("suspected postoperative intraabdominal bleed") and rectal haemorrhage ("bleeding from the rectum and in fecal matte") in a 29-year-old female patient who had essure (batch no.B42242) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 3 ((b)(6) 2007, (b)(6) 2009 and (b)(6) 2013) and prenatal care in 2009.Non tobacco user.Previously administered products included for an unreported indication: micronor from (b)(6) 2013 to (b)(6) 2013.Concurrent conditions included dysfunctional uterine bleeding.Family history included menorrhagia (mother), osteoporosis (mother), hypertensive (grandmother), hypercholesterolemia (father), hyperlipidemia (father), thyroid disorder (grandmother) and blood pressure high (father).Concomitant products included atomoxetine hydrochloride (strattera) from (b)(6) 2012 to (b)(6) 2017 for adhd, cetirizine hydrochloride (zyrtec) and fluticasone propionate (flonase) for allergic rhinitis, citalopram hydrobromide (celexa) from (b)(6) 2012 to (b)(6) 2017 for anxiety and depression, gabapentin from (b)(6) 2014 to (b)(6) 2014 for neuromyopathy, fluconazole (diflucan) from (b)(6) 2012 to (b)(6) 2017 for vaginal discharge as well as azithromycin, benzonatate, fluticasone and tramadol.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), headache ("head pain") and back pain ("severe back pain").On (b)(6) 2014, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, error in f_event_with_onset_srsns_nt:-6502-ora-06502: pl/sql: numeric or value error: character string buffer too small.Detail: line 1 ora-06512: at "bbs_owner.Pkg_custom_auto_narrative", line 10282 the patient was treated with surgery (total hysterectomy and bilateral salpingectomy, cystoscopy).Essure was removed on 3-apr-2014.At the time of the report, the pelvic pain, genital haemorrhage, intra-abdominal haemorrhage, rectal haemorrhage, menorrhagia, vaginal discharge, uterine cervical pain, dyspareunia, abdominal distension, swelling, rash pruritic, attention deficit/hyperactivity disorder, dysgeusia, fatigue, upper respiratory tract infection, sinusitis, malaise, pain, thinking abnormal, anal incontinence, urinary incontinence, diarrhoea, sinus pain, rhinorrhoea, lymphadenopathy, throat irritation, oral pruritus, asthenia, arthralgia, myalgia, muscle tightness, musculoskeletal stiffness, joint stiffness, abdominal pain lower, paraesthesia and hypoaesthesia had resolved, the autoimmune disorder, nausea, fibromyalgia, adverse food reaction, back pain, anxiety, decreased appetite and influenza like illness had not resolved and the neuromyopathy, burning sensation, pruritus, vulvovaginal pain, vulvovaginal burning sensation, coital bleeding, acne, vomiting, dental caries, gastric disorder, migraine, headache, plantar fasciitis, neck pain, allergy to metals, mental disorder, sneezing, burn oral cavity, discomfort, pyrexia, hot flush, chills, stress, gastrointestinal injury, flatulence, restless legs syndrome, dysstasia, pain in extremity, feeling cold, muscular weakness, feeling abnormal, mood swings, irritability, dysuria, urinary retention, arthropathy, bacterial vaginosis, vulvovaginal mycotic infection, hypertonic bladder, bladder pain, muscle spasms, neuralgia, chest pain, insomnia, palpitations, vertigo, spinal osteoarthritis, the last episode of visual impairment, dysphagia, confusional state, disorientation and memory impairment outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, acne, adverse food reaction, allergy to metals, alopecia, anaemia postoperative, anal incontinence, anxiety, arthralgia, arthropathy, asthenia, attention deficit/hyperactivity disorder, autoimmune disorder, back disorder, back pain, bacterial vaginosis, bladder pain, burn oral cavity, burning sensation, cervical radiculopathy, chest discomfort, chest pain, chills, coital bleeding, confusional state, cough, decreased appetite, dental caries, diarrhoea, discomfort, dislocation of vertebra, disorientation, dizziness, dysgeusia, dyspareunia, dysphagia, dyspnoea, dysstasia, dysuria, fatigue, feeling abnormal, feeling cold, fibromyalgia, flatulence, gastric disorder, gastrointestinal injury, gastrointestinal pain, genital haemorrhage, headache, hot flush, hypertonic bladder, hypoaesthesia, influenza like illness, insomnia, intra-abdominal haemorrhage, irritability, irritable bowel syndrome, joint stiffness, loss of libido, lymphadenopathy, malaise, memory impairment, menorrhagia, mental disorder, migraine, mood swings, muscle spasms, muscle tightness, muscular weakness, musculoskeletal stiffness, myalgia, nausea, neck pain, neuralgia, neuromyopathy, night sweats, oral pruritus, pain, pain in extremity, palpitations, paraesthesia, pelvic pain, plantar fasciitis, pruritus, pyrexia, rash pruritic, rectal haemorrhage, restless legs syndrome, rhinorrhoea, sciatica, sinus pain, sinusitis, sneezing, spinal osteoarthritis, stress, swelling, thinking abnormal, throat irritation, upper respiratory tract infection, urinary incontinence, urinary retention, uterine cervical pain, uterine enlargement, vaginal discharge, vertigo, vomiting, vulvovaginal burning sensation, vulvovaginal mycotic infection, vulvovaginal pain, weight decreased, the first episode of dyspepsia, the first episode of gastrooesophageal reflux disease, the first episode of rhinitis allergic, the first episode of visual impairment, the second episode of dyspepsia, the second episode of gastrooesophageal reflux disease, the second episode of rhinitis allergic and the second episode of visual impairment to be related to essure.The reporter commented: pfs-she had lost 1,000 cc of blood.He did a fulguration of the bleeding vessel and an evacuation of hemoperitoneum.Mr-number of coils remaining out on the: right side-3, left side-4.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: essure confirmation test.On (b)(6) 2014, abdominal ct scan was done due to pelvic pain.On (b)(6) 2015, ultrasound of gallbladder was done due to abdominal pain.On (b)(6) 2015, trans-vaginal ultrasound was done due to pelvic pain.On (b)(6) 2014, hysterosalphingogram-findings: essure micro-inserts are identified in the proximal fallopian tubes bilaterally, and appear appropriately located.Impression: bilateral obstructed fallopian tube status post essure procedure.On (b)(6) 2014, hcg- negative.On (b)(6) 2014, hcg test- negative.On (b)(6) 2014, tissue report-final diagnosis: uterus (90 grams) with bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: benign proliferative endometrium benign fallopian tubes with a right simple paratubal cyst present and ct abdômen.Pelvis (b)(6) 2014 impression: postoperative pneumoperitoneum.Postoperative subcutaneous emphysema ct pelvic impression: postoperative pneumoperitoneum.Postoperative subcutaneous emphysema and ct pelvic- impression: postop hysterectomy.Minimal pelvic ascites.On (b)(6) 2017, mri cervical spine without contrast- findings: minimal degenerative changes in the cervical spine, there is minimal posterior disk bulge a c4-5, c5-6 and c6-7, small central annular fissure at cs-6, no central canal or neural foraminal stenosis.Impression: minimal degenerative changes as described above.No evidence of central canal or neural foraminal stenosis.Normal cord signal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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.
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Search Alerts/Recalls
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