| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Inflammation (1932); Nausea (1970); Pain (1994); Rash (2033); Scar Tissue (2060); Urinary Tract Infection (2120); Vomiting (2144); Cramp(s) (2193); Sleep Dysfunction (2517); Heavier Menses (2666); No Code Available (3191)
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| Event Date 03/01/2009 |
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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 ('pain') in an adult female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous, tobacco user, parity 3, cervix inflammation, endometriosis of uterus and diabetes mellitus.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2018 to (b)(6) 2018 for menometrorrhagia.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain low"), loss of personal independence in daily activities ("hormonal changes: unable to function some days"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia),"), scar ("rashes or skin conditions type: huge boils under arms and on/ nickel to quarter size boils on inside of leg and arms the knots have left scar"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), vomiting ("migraines / headaches leading to vomiting"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)/mild cramping during menstruation"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), mood swings ("hormonal changes: severe mood swings"), mood altered ("hormonal changes: mood swings experience with menses"), hypersomnia ("hormonal changes: severe sleeping"), headache ("migraines / headaches"), furuncle ("rashes or skin conditions type: huge boils under arms and on/ nickel to quarter size boils on inside of leg and arms the knots have left scar"), genital pain ("genital pain"), abdominal pain ("abdominal pain"), abdominal pain lower ("abdominal pain lower") and allergy to metals ("rashes or skin conditions type: nickel to quarter size boils on inside of leg and arms the knots have left scar") and was found to have weight increased ("weight gain/ weight gain 40 pounds with in year").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, back pain, vaginal haemorrhage, menorrhagia, dyspareunia, alopecia, headache, abdominal pain and abdominal pain lower had resolved, the loss of personal independence in daily activities, scar, bladder disorder, urinary tract disorder, migraine, vomiting, nausea, tooth disorder, dysmenorrhoea, vaginal discharge, fatigue, weight increased, mood swings, mood altered, hypersomnia, genital pain and allergy to metals outcome was unknown and the furuncle was resolving.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, back pain, bladder disorder, dysmenorrhoea, dyspareunia, fatigue, furuncle, genital pain, headache, hypersomnia, loss of personal independence in daily activities, menorrhagia, migraine, mood altered, mood swings, nausea, pelvic pain, scar, tooth disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vomiting and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram -on (b)(6) 2009: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs+mr received: events hormonal changes, abnormal bleeding (vaginal, menorrhagia), rashes or skin conditions type: huge boils under arms and on bladder or urinary problems or changes , migraines/headaches, nausea, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), vaginal discharge, pain, fatigue, weight gain, hair loss, hormonal changes: unable to function some days, abdominal pain lower, abdominal pain, genital pain, hormonal changes: mood swings experience with menses, rashes or skin conditions type: nickel to huge boils under arms and on/ nickel to quarter size boils on inside of leg and arms the knots have left scar, severe sleeping were added.Lot number, medical history, lab data were added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance data; should any new and reportable information become available as a result, this will be provided in a supplementary 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 ('pain') and genital haemorrhage ('genital haemorrhage') in an adult female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous, tobacco user, parity 3, cervix inflammation, endometriosis of uterus, diabetes mellitus, contusion and sickness.Concomitant products included medroxyprogesterone acetate (depo provera) from 24-jan-2018 to 5-sep-2018 for menometrorrhagia as well as ibuprofen (motrin) from 2009 to 2018, ibuprofen;paracetamol (midol) from 2011 to 2018, paracetamol (tylenol) from 2009 to 2018 and sertraline hydrochloride (zoloft) from 2010 to 2011.On (b)(6) 2009, the patient had essure inserted.In march 2009, the patient experienced hyperaesthesia teeth ("dental problems : teeth sensitivity") and loose tooth ("loose teeth").In 2009, the patient experienced tooth loss ("dental problems : loss of multiple teeth").In 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) ,") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia) ,").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain low"), loss of personal independence in daily activities ("hormonal changes: unable to function some days"), scar ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), vomiting ("migraines / headaches leading to vomiting"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)/mild cramping during menstruation"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue/ tiredness"), alopecia ("hair loss"), mood swings ("hormonal changes: severe mood swings"), mood altered ("hormonal changes: mood swings experience with menses"), hypersomnia ("hormonal changes: severe sleeping/sleep issues"), headache ("migraines / headaches"), furuncle ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), genital pain ("genital pain"), abdominal pain ("abdominal pain"), abdominal pain lower ("abdominal pain lower"), allergy to metals ("rashes or skin conditions type: nickel to quater size boils on inside of leg and arms the knots have left scar"), depression ("neurological conditions or problems type-depression and anxiety"), anxiety ("neurological conditions or problems type-depression and anxiety"), coital bleeding ("vaginal bleeding after intercourse"), asthenia ("lack of energy"), trichorrhexis ("brittle hair"), female sexual dysfunction ("apareunia"), pollakiuria ("frequency urinary"), dysuria ("burning during urination/ discomfort/itching"), dysgeusia ("metallic taste in mouth"), gastrointestinal disorder ("gastrointestinal or digestive system condition type: bowel issue"), diarrhoea ("gastrointestinal or digestive system condition type: runny stool, diarrhoea"), visual impairment ("vision/eye problems-white spots"), vitreous floaters ("vision/eye problems- visual floaters"), adenomyosis ("adenomyosis disease"), cervicitis ("chronic cervicitis with squamous metaplasia"), hot flush ("hormonal changes describe:hot flashes"), genital haemorrhage (seriousness criterion medically significant), uterine cervical metaplasia ("squamous metaplasia"), sleep disorder ("sleep issues"), skin mass ("knots on inside of leg ,near pubic area and under arms") and micturition urgency ("urgent urination"), was found to have weight increased ("weight gain/ weight gain 40 pounds with in year") and underwent cholecystectomy ("cholecystectomy").The patient was treated with surgery (hysterectomy with bilateral salpingectomy and removal of teeth).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, back pain, vaginal haemorrhage, menorrhagia, migraine, dyspareunia, alopecia, headache, furuncle, abdominal pain, abdominal pain lower, coital bleeding, trichorrhexis and genital haemorrhage had resolved and the loss of personal independence in daily activities, scar, bladder disorder, urinary tract disorder, vomiting, nausea, tooth disorder, dysmenorrhoea, vaginal discharge, fatigue, weight increased, mood swings, mood altered, hypersomnia, genital pain, allergy to metals, hyperaesthesia teeth, loose tooth, depression, anxiety, asthenia, female sexual dysfunction, pollakiuria, dysuria, dysgeusia, gastrointestinal disorder, visual impairment, vitreous floaters, cervicitis, tooth loss, hot flush, uterine cervical metaplasia, cholecystectomy, sleep disorder, skin mass and micturition urgency outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, alopecia, anxiety, asthenia, back pain, bladder disorder, cervicitis, cholecystectomy, coital bleeding, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, dysuria, fatigue, female sexual dysfunction, furuncle, gastrointestinal disorder, genital haemorrhage, genital pain, headache, hot flush, hyperaesthesia teeth, hypersomnia, loose tooth, loss of personal independence in daily activities, menorrhagia, micturition urgency, migraine, mood altered, mood swings, nausea, pelvic pain, pollakiuria, scar, skin mass, sleep disorder, tooth disorder, tooth loss, trichorrhexis, urinary tract disorder, uterine cervical metaplasia, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters, vomiting and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 01-mar-2009: total bilateral occlusion; in april 2009: total bilateral occlusion.Lot number: 623222.Manufacture date: 2009-03 expiration date: 2012-03.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-jun-2019: quality-safety evaluation of product technical complaint.Incident we received a lot number 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and genital haemorrhage ('genital haemorrhage') in an adult female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous, tobacco user, parity 3, cervix inflammation, endometriosis of uterus, diabetes mellitus, contusion and sickness.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2018 to (b)(6) 2018 for menometrorrhagia as well as ibuprofen (motrin) from 2009 to 2018, ibuprofen;paracetamol (midol) from 2011 to 2018, paracetamol (tylenol) from 2009 to 2018 and sertraline hydrochloride (zoloft) from 2010 to 2011.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced hyperaesthesia teeth ("dental problems : teeth sensitivity") and loose tooth ("loose teeth").In 2009, the patient experienced tooth loss ("dental problems : loss of multiple teeth").In 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) ,") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia) ,").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain low"), loss of personal independence in daily activities ("hormonal changes: unable to function some days"), scar ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines / headaches"), vomiting ("migraines / headaches leading to vomiting"), nausea ("nausea"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)/mild cramping during menstruation"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue/ tiredness"), alopecia ("hair loss"), mood swings ("hormonal changes: severe mood swings"), mood altered ("hormonal changes: mood swings experience with menses"), hypersomnia ("hormonal changes: severe sleeping/sleep issues"), headache ("migraines / headaches"), furuncle ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), genital pain ("genital pain"), abdominal pain ("abdominal pain"), abdominal pain lower ("abdominal pain lower"), allergy to metals ("rashes or skin conditions type: nickel to quater size boils on inside of leg and arms the knots have left scar"), depression ("neurological conditions or problems type-depression and anxiety"), anxiety ("neurological conditions or problems type-depression and anxiety"), coital bleeding ("vaginal bleeding after intercourse"), asthenia ("lack of energy"), trichorrhexis ("brittle hair"), female sexual dysfunction ("apareunia"), pollakiuria ("frequency urinary"), dysuria ("burning during urination/ discomfort/itching"), dysgeusia ("metallic taste in mouth"), gastrointestinal disorder ("gastrointestinal or digestive system condition type: bowel issue"), diarrhoea ("gastrointestinal or digestive system condition type: runny stool, diarrhoea"), visual impairment ("vision/eye problems-white spots"), vitreous floaters ("vision/eye problems- visual floaters"), adenomyosis ("adenomyosis disease"), cervicitis ("chronic cervicitis with squamous metaplasia"), hot flush ("hormonal changes describe:hot flashes"), genital haemorrhage (seriousness criterion medically significant), uterine cervical metaplasia ("squamous metaplasia"), sleep disorder ("sleep issues"), skin mass ("knots on inside of leg ,near pubic area and under arms") and micturition urgency ("urgent urination"), was found to have weight increased ("weight gain/ weight gain 40 pounds with in year") and underwent cholecystectomy ("cholecystectomy").The patient was treated with surgery (hysterectomy with bilateral salpingectomy and removal of teeth).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, back pain, vaginal haemorrhage, menorrhagia, migraine, dyspareunia, alopecia, headache, furuncle, abdominal pain, abdominal pain lower, coital bleeding, trichorrhexis and genital haemorrhage had resolved and the loss of personal independence in daily activities, scar, bladder disorder, urinary tract disorder, vomiting, nausea, tooth disorder, dysmenorrhoea, vaginal discharge, fatigue, weight increased, mood swings, mood altered, hypersomnia, genital pain, allergy to metals, hyperaesthesia teeth, loose tooth, depression, anxiety, asthenia, female sexual dysfunction, pollakiuria, dysuria, dysgeusia, gastrointestinal disorder, visual impairment, vitreous floaters, cervicitis, tooth loss, hot flush, uterine cervical metaplasia, cholecystectomy, sleep disorder, skin mass and micturition urgency outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, alopecia, anxiety, asthenia, back pain, bladder disorder, cervicitis, cholecystectomy, coital bleeding, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, dysuria, fatigue, female sexual dysfunction, furuncle, gastrointestinal disorder, genital haemorrhage, genital pain, headache, hot flush, hyperaesthesia teeth, hypersomnia, loose tooth, loss of personal independence in daily activities, menorrhagia, micturition urgency, migraine, mood altered, mood swings, nausea, pelvic pain, pollakiuria, scar, skin mass, sleep disorder, tooth disorder, tooth loss, trichorrhexis, urinary tract disorder, uterine cervical metaplasia, vaginal discharge, vaginal haemorrhage, visual impairment, vitreous floaters, vomiting and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion; in (b)(6) 2009: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 31-may-2019: pfs and mr received : new events, "dental problems : teeth sensitivity, loose teeth, neurological conditions or problems type-depression and anxiety, vaginal bleeding after intercourse, lack of energy, brittle hair, apareunia, frequency urinary, burning during urination/ discomfort/itching, metallic taste in mouth, gastrointestinal or digestive system condition type: bowel issue, gastrointestinal or digestive system condition type: runny stool, diarrhea, vision/eye problems-white spots, vision/eye problems- visual floaters, adenomyosis disease, chronic cervicitis with squamous metaplasia, dental problems : loss of multiple teeth" were added.Outcome of events, "rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar, migraines, brittle hair" were changed to "recovered/resolved".New reporter contact information was added.Onset dates of events were added.Medical history was added.Lab data was added.Concomitant medications were added.Incident we received a lot number 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and genital haemorrhage ('genital haemorrhage') in a 25-year-old female patient who had essure (batch no.623222) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in november 2015, multiparous, tobacco user, parity 3, cervix inflammation, endometriosis of uterus, diabetes mellitus, contusion, sickness, rib pain, stones common duct, gallbladder disease, smoker and alcohol use.Current weight: 242 lbs (b)(6) 2018 pathology diagnosis: uterus, hysterectomy with bilateral salpingectomy (144 grams) (as written): adenomyosis.Chronic cervicitis with squamous metaplasia.Suppressed endometrium with features of progesterone effect.Complete cross-section of bilateral fallopian tubes.Negative for atypical hyperplasia, dysplasia, or malignancy.Concurrent conditions included constipation, abdominal pain upper, gallstones, transaminitis, uti, polycystic ovary, cyst of kidney, acquired, nicotine dependence, inborn error of bilirubin metabolism nos, discoloration urine, feeling hot, leiomyoma nos, bartholin's cyst, short of breath, hyperbilirubinemia, dilatation intrahepatic duct acquired, jaundice, rbc count increased and overweight.Concomitant products included diphenhydramine citrate;ibuprofen (motrin pm) from 2009 to 2018 for fever, medroxyprogesterone acetate (depo provera) from 24-jan-2018 to 5-sep-2018 for menometrorrhagia, morphine for pain nos as well as celecoxib (celexa), chlormezanone (restoril), docusate sodium (colace), hydromorphone hydrochloride (dilaudid), hydroxyzine, ibuprofen;paracetamol (midol) from 2011 to 2018, lamotrigine (lamictal), levofloxacin (lovenox), ondansetron (zofran), paracetamol (tylenol) from 2009 to 2018, piperacillin sodium;tazobactam sodium (zosyn), sertraline hydrochloride (zoloft) from 2010 to 2011, sultamicillin and venlafaxine hydrochloride (effexor).On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), furuncle ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), dysgeusia ("metallic taste in mouth") and skin mass ("knots on inside of leg ,near pubic area and under arms"), 27 days after insertion of essure.In march 2009, the patient experienced hyperaesthesia teeth ("dental problems : teeth sensitivity") and loose tooth ("loose teeth").On (b)(6) 2009, the patient experienced alopecia ("hair loss"), trichorrhexis ("brittle hair"), vaginal odour ("vaginal odor") and vaginal discharge ("vaginal discharge/ recurring vaginal discharge").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)") and vulvovaginal pain ("vaginal pain during and after intercourse").In 2009, the patient experienced tooth loss ("dental problems : loss of multiple teeth").On (b)(6) 2009, the patient experienced back pain ("back pain low"), migraine ("migraines / headaches"), vomiting ("migraines / headaches leading to vomiting"), nausea ("nausea"), fatigue ("fatigue/ tiredness"), headache ("migraines / headaches"), abdominal pain lower ("abdominal pain lower"), menometrorrhagia ("excessive menses with irregular cycles") and polymenorrhoea ("frequent menstrual").On (b)(6) 2009, the patient experienced hypersomnia ("hormonal changes: severe sleeping/sleep issues"), depression ("neurological conditions or problems type-depression and anxiety") and anxiety ("neurological conditions or problems type-depression and anxiety").On (b)(6) 2009, the patient experienced mood swings ("hormonal changes: severe mood swings").On (b)(6) 2010 the patient was found to have weight increased ("weight gain/ weight gain 40 pounds with in year") and experienced dysuria ("burning during urination/ discomfort/itching/dysuria") and hot flush ("hormonal changes describe:hot flashes").In 2010, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia) ,") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) ,").On (b)(6) 2015, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").On (b)(6) 2016, the patient experienced ovarian cyst ("ovarian cyst.Right side").On an unknown date, the patient experienced rash ("rash").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), loss of personal independence in daily activities ("hormonal changes: unable to function some days"), metrorrhagia ("bleeding in between menstrual cycle"), scar ("rashes or skin conditions type: huge boils under arms and on/ nickel to quater size boils on inside of leg and arms the knots have left scar"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)/mild cramping during menstruation/severe and shrp cramps"), mood altered ("hormonal changes: mood swings experience with menses"), genital pain ("genital pain"), abdominal pain ("abdominal pain"), allergy to metals ("rashes or skin conditions type: nickel to quater size boils on inside of leg and arms the knots have left scar"), coital bleeding ("vaginal bleeding after intercourse"), asthenia ("lack of energy"), pollakiuria ("frequency urinary"), gastrointestinal disorder ("gastrointestinal or digestive system condition type: bowel issue"), diarrhoea ("gastrointestinal or digestive system condition type: runny stool, diarrhoea"), visual impairment ("vision/eye problems-white spots"), vitreous floaters ("vision/eye problems- visual floaters"), adenomyosis ("adenomyosis disease"), cervicitis ("chronic cervicitis with squamous metaplasia"), metaplasia ("squamous metaplasia"), sleep disorder ("sleep issues"), micturition urgency ("urgent urination"), urinary tract infection ("uti") and burning micturition ("burning during urination/ discomfort/itching/urinary pain") and underwent cholecystectomy ("cholecystectomy").The patient was treated with bismuth subsalicylate (pepto bismol) and surgery (hysterectomy with bilateral salpingectomy and removal of teeth).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, back pain, metrorrhagia, menorrhagia, migraine, nausea, dysmenorrhoea, dyspareunia, alopecia, headache, furuncle, abdominal pain, abdominal pain lower, coital bleeding, trichorrhexis, female sexual dysfunction, dysgeusia, rash, menometrorrhagia, skin mass and vaginal haemorrhage had resolved and the loss of personal independence in daily activities, scar, bladder disorder, urinary tract disorder, vomiting, tooth disorder, vulvovaginal pain, fatigue, weight increased, mood swings, mood altered, hypersomnia, genital pain, allergy to metals, hyperaesthesia teeth, loose tooth, depression, anxiety, asthenia, pollakiuria, dysuria, gastrointestinal disorder, visual impairment, vitreous floaters, cervicitis, tooth loss, hot flush, metaplasia, cholecystectomy, sleep disorder, micturition urgency, ovarian cyst, urinary tract infection, polymenorrhoea, burning micturition, vaginal odour and vaginal discharge outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, alopecia, anxiety, asthenia, back pain, bladder disorder, cervicitis, cholecystectomy, coital bleeding, depression, diarrhoea, dysgeusia, dysmenorrhoea, dyspareunia, dysuria, fatigue, female sexual dysfunction, furuncle, gastrointestinal disorder, genital haemorrhage, genital pain, headache, hot flush, hyperaesthesia teeth, hypersomnia, loose tooth, loss of personal independence in daily activities, menometrorrhagia, menorrhagia, metaplasia, metrorrhagia, micturition urgency, migraine, mood altered, mood swings, nausea, ovarian cyst, pelvic pain, pollakiuria, polymenorrhoea, rash, scar, skin mass, sleep disorder, tooth disorder, tooth loss, trichorrhexis, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal odour, visual impairment, vitreous floaters, vomiting, vulvovaginal pain, weight increased and burning micturition to be related to essure.The reporter commented: current weight: 242 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29 kg/sqm.Cholangiogram - on (b)(6) 2015: limited evaluation demonstrating multiple retained calculi within either the common hepatic duct and! or proximal common bile duct.Computerised tomogram abdomen - on (b)(6) 2016: 1.Prominent intrahepatic and extrahepatic ductal dilatation with normal tapering of the distal common bile duct likely biliary ectasia.If clinical symptom's persist, suggest mrcp.2.Enlarged utems with peripheral calcifications likely calcified leiomyomas.3.Right ovarian probable benign eystie lesion.Follow-up ultrasound in 6-12 weeks suggested as per recommendations below.4.Decreased attenuation right vaginal wall, likely bartholin's cyst; on (b)(6) 2016: mild intra and extrahepatic biliary ductal dilatation with 2 distinct filling defects in distal common bile duct - appearance most likely representing choledocholithiasis - would recommend a follow up gastroenterology consultation and possible ercp.Hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion; in april 2009: total bilateral occlusion; on (b)(6) 2009: total bilateral occlusion.Lot number: 623222.Manufacture date: 2009-03 expiration date: 2012-03.Concerning the injury reported in this case the following once were described in patient medical records: diarrhea, vomiting, back pain, nausea, abdominal pain, cholecystectomy, uti, ovarian cyst, menometrorrhagia, metaplasia, polymenorrhoea, cervicitis.Most recent follow-up information incorporated above includes: on 4-oct-2019: pfs+ mr received- new events uti, uti, ovarian cyst, frequent menstrual, excessive menses with irregular cycles, vaginal odor, vaginal pain during and after intercourse, rash, bleeding in between menstrual cycle were added.Outcome of dysmenorrhea, menometrorrhagia, skin mass, nausea, dysgeusia, female sexual dysfunction updated to recovered / resolved.New reporters, height, lab data, medical history, treatment and concomitant drugs were added.Incident:we received a lot number 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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