| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Bacterial Infection (1735); Cyst(s) (1800); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Pain (1994); Rash (2033); Swelling (2091); Abnormal Vaginal Discharge (2123); Anxiety (2328); Arthralgia (2355); Depression (2361); Weight Changes (2607); Heavier Menses (2666); Nervous System Injury (2689)
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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 ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder type of disorder") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included seasonal allergy, obesity, depression, tmj syndrome, acne, ovarian cyst (drainage of cyst.), anxiety, varicose vein, gerd and joint pain.Concomitant products included cetirizine hydrochloride (zyrtec), cyclobenzaprine hydrochloride (flexeril), fluticasone propionate (flonase), folic acid, hydroxychloroquine phosphate (plaquenil), methocarbamol, methotrexate, prednisone, pregabalin (lyrica) and sulfasalazine.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hormone level abnormal ("hormonal changes,"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), vaginal infection ("infection (bladder/ urinary tract/vaginal),") with vaginal discharge, cystitis ("infection (bladder/ urinary tract/vaginal),"), urinary tract infection ("infection (bladder/ urinary tract/vaginal),"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), allergy to metals ("nickel allergy") with rash, tooth disorder ("dental problems"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), alopecia ("hair loss"), mental disorder ("psychological or psychiatric problems"), abdominal pain ("abdominal pain"), pain in extremity ("shooting pains down leg"), bladder disorder ("bladder or urinary problems or changes") and weight fluctuation ("weight gain / loss").The patient was treated with phentermine, sertraline (zoloft), meloxicam, bupropion hydrochloride (wellbutrin sr), oxycodone, lubiprostone (amitiza), norethisterone (micronor) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain was resolving, the genital haemorrhage, autoimmune disorder, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, vaginal infection, cystitis, urinary tract infection, urinary tract disorder, migraine, headache, nausea, allergy to metals, tooth disorder, nervous system disorder, dyspareunia, fatigue, gastrointestinal disorder, alopecia, abdominal pain, bladder disorder and weight fluctuation outcome was unknown and the dysmenorrhoea and pain in extremity had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, autoimmune disorder, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, menorrhagia, mental disorder, migraine, nausea, nervous system disorder, pain in extremity, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: per pfs the implant date of essure was (b)(6) 2011.(b)(6) diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs and mr received: reporters details added.Events added as hormonal changes, abnormal bleeding (general), abnormal bleeding (vaginal, menorrhagia), allergic or hypersensitivity reaction, infection (bladder/ urinary tract/vaginal), apareunia (inability to have sexual intercourse), psychological or psychiatric problems condition, autoimmune disorder type of disorder, rashes or skin conditions type, bladder or urinary problems or changes, migraines / headaches, salpingectomy (bilateral removal of fallopian tubes), nausea, dental problems, neurological conditions or problems type, nickel allergy, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pain, vaginal discharge, fatigue, weight gain / loss specify which one, gastrointestinal or digestive system condition type, hair loss.Concomitant, historical drugs and treatment drugs were added.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submit 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 pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder type of disorder") in a 33-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included seasonal allergy, obesity, depression, tmj syndrome, acne, ovarian cyst (drainage of cyst.), anxiety, varicose vein, gerd, joint pain, dysuria and hematuria.Concomitant products included cetirizine hydrochloride (zyrtec), cyclobenzaprine hydrochloride (flexeril), fluticasone propionate (flonase), folic acid, hydroxychloroquine phosphate (plaquenil), methocarbamol, methotrexate, prednisone, pregabalin (lyrica) and sulfasalazine.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hormone level abnormal ("hormonal changes,"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), vaginal infection ("infection (bladder/ urinary tract/vaginal),") with vaginal discharge, cystitis ("infection (bladder/ urinary tract/vaginal),"), urinary tract infection ("infection (bladder/ urinary tract/vaginal),"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), allergy to metals ("nickel allergy/reaction type: i can not put on any jewelry") with rash, tooth disorder ("dental problems"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), alopecia ("hair loss"), mental disorder ("psychological or psychiatric problems"), abdominal pain ("abdominal pain"), pain in extremity ("shooting pains down leg"), bladder disorder ("bladder or urinary problems or changes"), weight fluctuation ("weight gain / loss"), arthralgia ("hormonal changes describe: low libido"), rheumatoid arthritis ("autoimmune disorder: type of disorder: rheumatoid arthritis"), fibromyalgia ("neurological conditions or problems type: fibromyalgia"), diarrhoea ("gastrointestinal or digestive system condition type: diarrhea") and libido decreased ("hormonal changes describe: low libido").The patient was treated with phentermine, sertraline (zoloft), meloxicam, bupropion hydrochloride (wellbutrin sr), oxycodone, lubiprostone (amitiza), norethisterone (micronor) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain was resolving, the genital haemorrhage, autoimmune disorder, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, vaginal infection, cystitis, urinary tract infection, urinary tract disorder, migraine, headache, nausea, allergy to metals, tooth disorder, nervous system disorder, dyspareunia, fatigue, gastrointestinal disorder, alopecia, abdominal pain, bladder disorder, weight fluctuation, arthralgia, rheumatoid arthritis, fibromyalgia, diarrhoea and libido decreased outcome was unknown and the dysmenorrhoea and pain in extremity had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, arthralgia, autoimmune disorder, bladder disorder, cystitis, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, fibromyalgia, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, libido decreased, menorrhagia, mental disorder, migraine, nausea, nervous system disorder, pain in extremity, pelvic pain, rheumatoid arthritis, tooth disorder, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: per pfs the implant date of essure was (b)(6) 2011.Current weight 220 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion smear cervix - on an unknown date: abnormal.¿concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, abdominal pain, vaginal bleeding, (confirming pelvic pain), back pain, anxiety, depression, dyspareunia and vaginal discharge." most recent follow-up information incorporated above includes: on 5-jun-2018: pfs+mr received: new events: rheumatoid arthritis, fibromyalgia, diarrhea, libido decreased, arthralgia were added.Reporter 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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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder type of disorder") in a 33-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included seasonal allergy, obesity, depression, tmj syndrome, acne, ovarian cyst (drainage of cyst.), anxiety, varicose vein, gerd, joint pain, dysuria and hematuria.Concomitant products included cetirizine hydrochloride (zyrtec), cyclobenzaprine hydrochloride (flexeril), fluticasone propionate (flonase), folic acid, hydroxychloroquine phosphate (plaquenil), methocarbamol, methotrexate, prednisone, pregabalin (lyrica) and sulfasalazine.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hormone level abnormal ("hormonal changes,"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), vaginal infection ("infection (bladder/ urinary tract/vaginal),") with vaginal discharge, cystitis ("infection (bladder/ urinary tract/vaginal),"), urinary tract infection ("infection (bladder/ urinary tract/vaginal),"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), allergy to metals ("nickel allergy/reaction type: i can not put on any jewelry") with rash, tooth disorder ("dental problems"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), alopecia ("hair loss"), mental disorder ("psychological or psychiatric problems"), abdominal pain ("abdominal pain"), pain in extremity ("shooting pains down leg"), bladder disorder ("bladder or urinary problems or changes"), weight fluctuation ("weight gain / loss"), arthralgia ("knee pain"), rheumatoid arthritis ("autoimmune disorder: type of disorder: rheumatoid arthritis"), fibromyalgia ("neurological conditions or problems type: fibromyalgia"), diarrhoea ("gastrointestinal or digestive system condition type: diarrhea") and libido decreased ("hormonal changes describe: low libido").The patient was treated with phentermine, sertraline (zoloft), meloxicam, bupropion hydrochloride (wellbutrin sr), oxycodone, lubiprostone (amitiza), norethisterone (micronor) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain was resolving, the genital haemorrhage, autoimmune disorder, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, vaginal infection, cystitis, urinary tract infection, urinary tract disorder, migraine, headache, nausea, allergy to metals, tooth disorder, nervous system disorder, dyspareunia, fatigue, gastrointestinal disorder, alopecia, abdominal pain, bladder disorder, weight fluctuation, arthralgia, rheumatoid arthritis, fibromyalgia, diarrhoea and libido decreased outcome was unknown and the dysmenorrhoea and pain in extremity had resolved.The reporter considered abdominal pain, allergy to metals, alopecia, arthralgia, autoimmune disorder, bladder disorder, cystitis, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, fibromyalgia, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, libido decreased, menorrhagia, mental disorder, migraine, nausea, nervous system disorder, pain in extremity, pelvic pain, rheumatoid arthritis, tooth disorder, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: per pfs the implant date of essure was (b)(6) 2011.Current weight 220 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 25-apr-2013: total bilateral occlusion smear cervix - on an unknown date: abnormal.¿concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, abdominal pain, vaginal bleeding, (confirming pelvic pain), back pain, anxiety, depression, dyspareunia and vaginal discharge." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-aug-2018: quality safety evaluation of product technical complaint.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 pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("autoimmune disorder type of disorder") in a 33-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included seasonal allergy, obesity, tmj syndrome, acne, ovarian cyst (drainage of cyst.), anxiety, varicose vein, gerd, joint pain, dysuria and hematuria.Concomitant products included cetirizine hydrochloride, cyclobenzaprine hydrochloride (flexeril), fluticasone propionate (flonase), folic acid, hydroxychloroquine phosphate (plaquenil), methocarbamol, methotrexate, prednisone, pregabalin (lyrica) and sulfasalazine.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), vaginal infection ("infection (bladder/ urinary tract/vaginal),") with vaginal discharge, cystitis ("infection (bladder/ urinary tract/vaginal),"), urinary tract infection ("infection (bladder/ urinary tract/vaginal),"), urinary tract disorder ("bladder or urinary problems or changes"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), allergy to metals ("nickel allergy/reaction type: i can not put on any jewelry") with rash, tooth disorder ("dental problems"), nervous system disorder ("neurological conditions or problems type"), dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), gastrointestinal disorder ("gastrointestinal or digestive system condition type"), alopecia ("hair loss"), mental disorder ("psychological or psychiatric problems"), abdominal pain ("abdominal pain"), pain in extremity ("shooting pains down leg"), bladder disorder ("bladder or urinary problems or changes"), weight fluctuation ("weight gain / loss"), arthralgia ("knee pain"), rheumatoid arthritis ("autoimmune disorder: type of disorder: rheumatoid arthritis"), fibromyalgia ("neurological conditions or problems type: fibromyalgia"), diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), libido decreased ("hormonal changes describe: low libido"), abdominal distension ("bloating"), mood swings ("mood swing"), depression ("depression") and abdominal pain lower ("cramps") and was found to have hormone level abnormal ("hormonal changes,").The patient was treated with bupropion hydrochloride (wellbutrin), lubiprostone (amitiza), meloxicam, norethisterone (micronor), oxycodone, phentermine, sertraline hydrochloride (zoloft) and surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain and abdominal pain lower was resolving, the genital haemorrhage, autoimmune disorder, vaginal haemorrhage, menorrhagia, hormone level abnormal, female sexual dysfunction, vaginal infection, cystitis, urinary tract infection, urinary tract disorder, migraine, headache, nausea, allergy to metals, tooth disorder, nervous system disorder, dyspareunia, fatigue, gastrointestinal disorder, alopecia, abdominal pain, bladder disorder, weight fluctuation, arthralgia, rheumatoid arthritis, fibromyalgia, diarrhoea, libido decreased, abdominal distension, depression and mood swings outcome was unknown and the dysmenorrhoea and pain in extremity had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, arthralgia, autoimmune disorder, bladder disorder, cystitis, depression, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, fibromyalgia, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, libido decreased, menorrhagia, mental disorder, migraine, mood swings, nausea, nervous system disorder, pain in extremity, pelvic pain, rheumatoid arthritis, tooth disorder, urinary tract disorder, urinary tract infection, vaginal haemorrhage, vaginal infection and weight fluctuation to be related to essure.The reporter commented: per pfs the implant date of essure was (b)(6) 2011.Current weight 220 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: total bilateral occlusion.Smear cervix - on an unknown date: results: abnormal.¿concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, abdominal pain, vaginal bleeding, (confirming pelvic pain), back pain, anxiety, depression, dyspareunia and vaginal discharge." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-nov-2018: pfs received:event bloating,mood swing,depression,cramps added.Outcome of event cramps added as recovering.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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