| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Respiratory Distress (2045); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Arthralgia (2355); Malaise (2359); Loss of consciousness (2418); Neck Pain (2433); Abdominal Cramps (2543); Weight Changes (2607); Fibrosis (3167); No Code Available (3191)
|
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain, even when not menstruating/ pain") and loss of consciousness ("passed out") in a (b)(6) female patient who had essure (batch no.C95073) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "ablation".The patient's past medical history included dysplasia, hypertension, irritable bowel syndrome, shortness of breath, low grade squamous intraepithelial lesion, gastroesophageal reflux disease and sexually transmitted disease nos.Concurrent conditions included obesity.Concomitant products included omeprazole since (b)(6) 2014, propranolol since (b)(6) 2014, tramadol since (b)(6) 2014 and trazodone since (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fatigue ("chronic fatigue"), weight increased ("weight gain"), alopecia ("hair loss"), migraine ("migraines"), urinary tract infection ("urinary tract infection"), mood swings ("mood swings"), blister ("blisters"), headache ("headaches /my head is hurting"), nausea ("nausea /nauseousness"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), irritable bowel syndrome ("irritable bowel syndrome"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), visual impairment ("vision problems") and eye disorder ("eye problems").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), loss of consciousness (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping and lower abdominal pain, even when not menstruating"), back pain ("severe lower back pain, even when not menstruating"), menorrhagia ("abnormally heavy menstrual bleeding/ abnormal bleeding (menorrhagia)"), weight decreased ("weight loss"), urinary incontinence ("urinary incontinence"), rash pruritic ("rashes; itching"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), arthralgia ("hip and knee/ ankle/ joint pain"), neck pain ("neck pain"), spinal pain ("lower spine pain"), uterine pain ("uterine pain"), abdominal pain ("abdominal pain"), fat tissue increased ("tumor / teratoma / cancer (fatty tissue build up)"), malaise ("sick"), diarrhoea ("diarrhea"), abdominal pain upper ("stomach pain / stomach cramp"), ear pain ("my ears is hurting") and cough ("coughing").The patient was treated with surgery (bigger surgery).Essure treatment was not changed.At the time of the report, the pelvic pain, dysmenorrhoea, abdominal pain lower, back pain, menorrhagia, dyspareunia, fatigue, weight increased, weight decreased, alopecia, urinary incontinence, rash pruritic, migraine and fibromyalgia had not resolved and the loss of consciousness, vaginal haemorrhage, urinary tract infection, mood swings, blister, headache, nausea, allergy to metals, vaginal discharge, irritable bowel syndrome, bladder disorder, urinary tract disorder, visual impairment, eye disorder, arthralgia, neck pain, spinal pain, uterine pain, fat tissue increased, malaise, diarrhoea, abdominal pain upper, ear pain and cough outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, back pain, bladder disorder, blister, cough, diarrhoea, dysmenorrhoea, dyspareunia, ear pain, eye disorder, fat tissue increased, fatigue, fibromyalgia, headache, irritable bowel syndrome, loss of consciousness, malaise, menorrhagia, migraine, mood swings, nausea, neck pain, pelvic pain, rash pruritic, spinal pain, urinary incontinence, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: plaintiff was investigating removal options, as she has not yet been able to undergo surgery to remove the essure micro-inserts.She was able to have surgery, now to the bigger surgery, it was painful and they should give me something for pain before and after.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: full occlusion of fallopian tubes confirmed.Current weight (b)(6) lbs.Concerning the injuries reported in this case, the following were described/confirmed in patient¿s medical records: dysmenorrhea, joint pain/muscle pain, menorrhagia, migraine, nausea, heavy vaginal bleeding and urinary tract infection.Concerning the injuries reported in this case, the following ones were reported via social media: malaise, diarrhea, abdominal pain upper, ear pain, cough, passed out.Most recent follow-up information incorporated above includes: on (b)(6) 2018: case is incident.Reporter information added.Event added per social media sick, diarrhea, stomach pain, my ear is hurting, coughing, i almost passed out.Event clubbed: nauseousness, my head is hurting.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.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain, even when not menstruating/ pain") and loss of consciousness ("passed out") in a 44-year-old female patient who had essure (batch no.C95073) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "ablation".The patient's past medical history included dysplasia, hypertension, irritable bowel syndrome, shortness of breath, low grade squamous intraepithelial lesion, gastroesophageal reflux disease and sexually transmitted disease nos.Concurrent conditions included obesity.Concomitant products included omeprazole since (b)(6) 2014, propranolol since (b)(6) 2014, tramadol since (b)(6) 2014 and trazodone since (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fatigue ("chronic fatigue"), weight increased ("weight gain"), alopecia ("hair loss"), migraine ("migraines"), urinary tract infection ("urinary tract infection"), mood swings ("mood swings"), blister ("blisters"), headache ("headaches /my head is hurting"), nausea ("nausea /nauseousness"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), irritable bowel syndrome ("irritable bowel syndrome"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), visual impairment ("vision problems") and eye disorder ("eye problems").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), loss of consciousness (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping and lower abdominal pain, even when not menstruating"), back pain ("severe lower back pain, even when not menstruating"), menorrhagia ("abnormally heavy menstrual bleeding/ abnormal bleeding (menorrhagia)"), weight decreased ("weight loss"), urinary incontinence ("urinary incontinence"), rash pruritic ("rashes; itching"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), arthralgia ("hip and knee/ ankle/ joint pain"), neck pain ("neck pain"), spinal pain ("lower spine pain"), uterine pain ("uterine pain"), abdominal pain ("abdominal pain"), fat tissue increased ("tumor / teratoma / cancer (fatty tissue build up)"), malaise ("sick"), diarrhoea ("diarrhea"), abdominal pain upper ("stomach pain / stomach cramp"), ear pain ("my ears is hurting") and cough ("coughing").The patient was treated with surgery (bigger surgery).Essure treatment was not changed.At the time of the report, the pelvic pain, dysmenorrhoea, abdominal pain lower, back pain, menorrhagia, dyspareunia, fatigue, weight increased, weight decreased, alopecia, urinary incontinence, rash pruritic, migraine and fibromyalgia had not resolved and the loss of consciousness, vaginal haemorrhage, urinary tract infection, mood swings, blister, headache, nausea, allergy to metals, vaginal discharge, irritable bowel syndrome, bladder disorder, urinary tract disorder, visual impairment, eye disorder, arthralgia, neck pain, spinal pain, uterine pain, fat tissue increased, malaise, diarrhoea, abdominal pain upper, ear pain and cough outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, back pain, bladder disorder, blister, cough, diarrhoea, dysmenorrhoea, dyspareunia, ear pain, eye disorder, fat tissue increased, fatigue, fibromyalgia, headache, irritable bowel syndrome, loss of consciousness, malaise, menorrhagia, migraine, mood swings, nausea, neck pain, pelvic pain, rash pruritic, spinal pain, urinary incontinence, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: plaintiff was investigating removal options, as she has not yet been able to undergo surgery to remove the essure micro-inserts.She was able to have surgery, now to the bigger surgery, it was painful and they should give me something for pain before and after.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: full occlusion of fallopian tubes confirmed.Current weight 225.00 lbs.Concerning the injuries reported in this case, the following were described/confirmed in patient¿s medical records: dysmenorrhea, joint pain/muscle pain, menorrhagia, migraine, nausea, heavy vaginal bleeding and urinary tract infection.Concerning the injuries reported in this case, the following ones were reported via social media:malaise, diarrhea, abdominal pain upper, ear pain, cough, passed out.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-aug-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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain, even when not menstruating/ pain") and loss of consciousness ("passed out") in a 44-year-old female patient who had essure (batch no.C95073) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "ablation".The patient's past medical history included dysplasia, hypertension, irritable bowel syndrome, shortness of breath, low grade squamous intraepithelial lesion, gastroesophageal reflux disease and sexually transmitted disease nos.Concurrent conditions included obesity.Concomitant products included omeprazole since (b)(6) 2014, propranolol since (b)(6) 2014, tramadol since (b)(6) 2014 and trazodone since (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fatigue ("chronic fatigue"), weight increased ("weight gain"), alopecia ("hair loss"), migraine ("migraines"), urinary tract infection ("urinary tract infection"), mood swings ("mood swings"), blister ("blisters"), headache ("headaches /my head is hurting"), nausea ("nausea /nauseousness"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), irritable bowel syndrome ("irritable bowel syndrome"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), visual impairment ("vision problems"), eye disorder ("eye problems") and depression ("depression").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), loss of consciousness (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping and lower abdominal pain, even when not menstruating"), back pain ("severe lower back pain, even when not menstruating"), menorrhagia ("abnormally heavy menstrual bleeding/ abnormal bleeding (menorrhagia)"), weight decreased ("weight loss"), urinary incontinence ("urinary incontinence"), rash pruritic ("rashes; itching / rash or skin conditions"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), arthralgia ("hip and knee/ ankle/ joint pain"), neck pain ("neck pain"), spinal pain ("lower spine pain"), uterine pain ("uterine pain"), abdominal pain ("abdominal pain"), fat tissue increased ("tumor / teratoma / cancer (fatty tissue build up)"), malaise ("sick"), diarrhoea ("diarrhea"), abdominal pain upper ("stomach pain / stomach cramp"), ear pain ("my ears is hurting") and cough ("coughing").The patient was treated with surgery (bigger surgery).Essure treatment was not changed.At the time of the report, the pelvic pain, abdominal pain lower, back pain, neck pain, spinal pain, uterine pain, abdominal pain, abdominal pain upper, ear pain and depression was resolving, the loss of consciousness, vaginal haemorrhage, urinary tract infection, mood swings, blister, headache, nausea, allergy to metals, vaginal discharge, irritable bowel syndrome, bladder disorder, urinary tract disorder, visual impairment, eye disorder, arthralgia, fat tissue increased, malaise, diarrhoea and cough outcome was unknown, the dysmenorrhoea, menorrhagia, dyspareunia, fatigue, weight increased, weight decreased, urinary incontinence, migraine and fibromyalgia had not resolved and the alopecia and rash pruritic had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, back pain, bladder disorder, blister, cough, depression, diarrhoea, dysmenorrhoea, dyspareunia, ear pain, eye disorder, fat tissue increased, fatigue, fibromyalgia, headache, irritable bowel syndrome, loss of consciousness, malaise, menorrhagia, migraine, mood swings, nausea, neck pain, pelvic pain, rash pruritic, spinal pain, urinary incontinence, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: plaintiff was investigating removal options, as she has not yet been able to undergo surgery to remove the essure micro-inserts.She was able to have surgery, now to the bigger surgery, it was painful and they should give me something for pain before and after.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: full occlusion of fallopian tubes confirmed.Current weight 225.00 lbs.Concerning the injuries reported in this case, the following were described/confirmed in patient¿s medical records: dysmenorrhea, joint pain/muscle pain, menorrhagia, migraine, nausea, heavy vaginal bleeding and urinary tract infection.Concerning the injuries reported in this case, the following ones were reported via social media:malaise, diarrhea, abdominal pain upper, ear pain, cough, passed out.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-oct-2018: pfs received.Date of removal was added.Added event depression.Updated onset date of events.Updated outcome of events.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain, even when not menstruating/ pain') and loss of consciousness ('passed out') in a 44-year-old female patient who had essure (batch no.C95073) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "ablation".The patient's medical history included dysplasia, hypertension, irritable bowel syndrome, shortness of breath, low grade squamous intraepithelial lesion, gastroesophageal reflux disease and sexually transmitted disease nos.Concurrent conditions included obesity.Concomitant products included omeprazole since (b)(6) 2014, propranolol since (b)(6) 2014, tramadol since 10-oct-2014 and trazodone since (b)(6)2014.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced dysmenorrhoea ("abnormally severe menstrual pain/ dysmenorrhea (cramping)"), dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)"), fatigue ("chronic fatigue"), alopecia ("hair loss"), migraine ("migraines"), urinary tract infection ("urinary tract infection"), mood swings ("mood swings"), blister ("blisters"), headache ("headaches /my head is hurting"), nausea ("nausea /nauseousness"), allergy to metals ("nickel allergy"), vaginal discharge ("vaginal discharge"), irritable bowel syndrome ("irritable bowel syndrome"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), visual impairment ("vision problems"), eye disorder ("eye problems") and depression ("depression") and was found to have weight increased ("weight gain").In (b)(6) 2017, the patient experienced fibromyalgia ("fibromyalgia").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), loss of consciousness (seriousness criterion medically significant), abdominal pain lower ("severe abdominal cramping and lower abdominal pain, even when not menstruating"), back pain ("severe lower back pain, even when not menstruating"), menorrhagia ("abnormally heavy menstrual bleeding/ abnormal bleeding (menorrhagia)"), urinary incontinence ("urinary incontinence"), rash pruritic ("rashes; itching / rash or skin conditions"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), arthralgia ("hip and knee/ ankle/ joint pain"), neck pain ("neck pain"), spinal pain ("lower spine pain"), uterine pain ("uterine pain"), abdominal pain ("abdominal pain"), fat tissue increased ("tumor / teratoma / cancer (fatty tissue build up)"), malaise ("sick"), diarrhoea ("diarrhea"), abdominal pain upper ("stomach pain / stomach cramp"), ear pain ("my ears is hurting"), cough ("coughing") and nightmare ("nightmare") and was found to have weight decreased ("weight loss").The patient was treated with surgery (bigger surgery).Essure treatment was not changed.At the time of the report, the pelvic pain, abdominal pain lower, back pain, neck pain, spinal pain, uterine pain, abdominal pain, abdominal pain upper, ear pain and depression was resolving, the loss of consciousness, vaginal haemorrhage, urinary tract infection, mood swings, blister, headache, nausea, allergy to metals, vaginal discharge, irritable bowel syndrome, bladder disorder, urinary tract disorder, visual impairment, eye disorder, arthralgia, fat tissue increased, malaise, diarrhoea, cough and nightmare outcome was unknown, the dysmenorrhoea, menorrhagia, dyspareunia, fatigue, weight increased, weight decreased, urinary incontinence, migraine and fibromyalgia had not resolved and the alopecia and rash pruritic had resolved.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, back pain, bladder disorder, blister, cough, depression, diarrhoea, dysmenorrhoea, dyspareunia, ear pain, eye disorder, fat tissue increased, fatigue, fibromyalgia, headache, irritable bowel syndrome, loss of consciousness, malaise, menorrhagia, migraine, mood swings, nausea, neck pain, nightmare, pelvic pain, rash pruritic, spinal pain, urinary incontinence, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and weight increased to be related to essure.The reporter commented: plaintiff was investigating removal options, as she has not yet been able to undergo surgery to remove the essure micro-inserts.She was able to have surgery, now to the bigger surgery, it was painful and they should give me something for pain before and after.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Hysterosalpingogram - on 01-jan-2015: results: full occlusion of fallopian tubes confirmed.Current weight 225.00 lbs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received: newly added events- nightmare, reporter was added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
