| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Tinnitus (2103); Urinary Tract Infection (2120)
|
| Event Date 01/01/2012 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain") and urinary tract infection ("utis") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urinary tract infection (seriousness criterion medically significant), nausea ("nausea"), pain ("pain"), fatigue ("chronic fatigue"), headache ("headaches"), dizziness ("dizziness"), tinnitus ("tinnitus"), migraine ("migraines") and tooth disorder ("dental problems").The patient was treated with surgery (she had surgery to remove the essure implant).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, urinary tract infection, nausea, pain, fatigue, headache, dizziness, tinnitus, migraine and tooth disorder outcome was unknown.The reporter considered migraine, pelvic pain and tooth disorder to be related to essure.The reporter provided no causality assessment for dizziness, fatigue, headache, nausea, pain, tinnitus and urinary tract infection with essure.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known possible undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2017: lawyer added from legal document.Reporter details, start date as (b)(6) 2012 (previously reported as 2011) and stop date as (b)(6) 2014, and updated action taken as drug withdrawn (previously reported as dose not change) and added events migraines, chronic pain, dental problems.Company causality comment 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.
|
| |
|
Manufacturer Narrative
|
|
E was initially received via regulatory authority (food and drug administration, reference number: (b)(4).On 24-sep-2014.The most recent information was received on 02-oct-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain"), urinary tract infection ("utis / infection (bladder/ urinary tract/vaginal) type: uti (recurrent episodes),") and peritonsillar abscess ("infection: peritonsillar abscess") in a 42-year-old female patient who had essure (batch no.901325/919033) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included neck pain, spondylosis, arthroscopy, back pain, buttock pain, breast operation, knee operation and rhinoplasty.Previously administered products included for an unreported indication: birth control pill.Concurrent conditions included diarrhea, oral herpes, allergic rhinitis, attention deficit/hyperactivity disorder and fever.Concomitant products included bupropion (wellbutrin).In january 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia") and gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: gerd").On 16-jan-2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urinary tract infection (seriousness criterion medically significant), nausea ("nausea"), pain ("pain"), the first episode of fatigue ("chronic fatigue"), headache ("headaches"), migraine ("migraines"), uterine leiomyoma ("hormonal changes describe: uterine fibroid next to left essure coil"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hyperacusis ("allergic or hypersensitivity reaction type: sound sensitivities"), photophobia ("allergic or hypersensitivity reaction type: light sensitivities"), food allergy ("allergic or hypersensitivity reaction type: food"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), anxiety ("psychological or psychiatric problems condition: anxiety"), rash ("rashes or skin conditions type: rashes"), muscular weakness ("neurological conditions or problems type: muscle weakness"), vaginal discharge ("vaginal discharge"), weight decreased ("weight gain / loss specify which one: weight loss"), bladder disorder ("bladder or urinary problems or changes") and urinary tract disorder ("urinary tract disorder").In 2013, the patient experienced tooth disorder ("dental problems"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and visual impairment ("vision/eye problems type: rapid deterioration of vision").In february 2014, the patient experienced streptococcal infection ("infection (other) describe: strep a"), peritonsillar abscess (seriousness criterion medically significant) and epstein-barr virus infection ("infection (other); ebv").On an unknown date, 8 months 24 days after insertion of essure, the patient experienced dizziness ("dizziness"), tinnitus ("tinnitis"), depression ("psychological or psychiatric problems condition: depression"), cyst ("reproductive system disorder or condition type of: cyst"), reading disorder ("inability to read"), agraphia ("inability to write,"), the second episode of fatigue ("fatigue"), arthralgia ("hip pain"), sciatica ("sciatic pain") and dysgeusia ("metal tatse").On an unknown date, the patient experienced allergy to metals ("nickel allergy").The patient was treated with antibiotics and surgery (hysterectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, pain, dizziness, tinnitus, tooth disorder, uterine leiomyoma, hyperacusis, photophobia, food allergy, peritonsillar abscess, epstein-barr virus infection, anxiety, depression, fibromyalgia, rash, cyst, muscular weakness, reading disorder, agraphia, allergy to metals, dysmenorrhoea, vaginal discharge, visual impairment, the last episode of fatigue, weight decreased, bladder disorder, urinary tract disorder, arthralgia and sciatica outcome was unknown and the urinary tract infection, nausea, headache, migraine, vaginal haemorrhage, menorrhagia, female sexual dysfunction, gastrooesophageal reflux disease and dysgeusia was resolving.The reporter provided no causality assessment for dizziness, headache, nausea, pain, tinnitus, urinary tract infection and the first episode of fatigue with essure.The reporter considered agraphia, allergy to metals, anxiety, arthralgia, bladder disorder, cyst, depression, dysgeusia, dysmenorrhoea, dyspareunia, epstein-barr virus infection, female sexual dysfunction, fibromyalgia, food allergy, gastrooesophageal reflux disease, hyperacusis, menorrhagia, migraine, muscular weakness, pelvic pain, peritonsillar abscess, photophobia, rash, reading disorder, sciatica, streptococcal infection, tooth disorder, urinary tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and the second episode of fatigue to be related to essure.The reporter commented: another expiration date for essure is nov-2014.Current weight: 125 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on 9-oct-2012: total bilateral occlusion lot number: 901325 manufacture date: sep-2011 expiration date: sep-2014.Lot number: 919033 manufacture date: nov-2011 expiration date: nov-2014.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 2-oct-2018: plaintiff fact sheet received- outcome of gastrooesophageal reflux disease, headaches, migraine updated to recovering / resolving.New reporter, concomitant and treatment medication were added.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
|
|
E was initially received via regulatory authority (food and drug administration, reference number: mw5037258) on 24-sep-2014.The most recent information was received on 20-jun-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain"), urinary tract infection ("utis / infection (bladder/ urinary tract/vaginal) type: uti (recurrent episodes),") and peritonsillar abscess ("infection: peritonsillar abscess") in a female patient who had essure (batch no.901325, 919033) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included neck pain, spondylosis, arthroscopy, back pain, buttock pain, breast operation, knee operation and rhinoplasty.Previously administered products included for an unreported indication: birth control pill.Concurrent conditions included diarrhea, oral herpes, allergic rhinitis, attention deficit/hyperactivity disorder and fever.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced nausea ("nausea") and pain ("pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urinary tract infection (seriousness criterion medically significant), the first episode of fatigue ("chronic fatigue"), headache ("headaches"), dizziness ("dizziness"), tinnitus ("tinnitis"), migraine ("migraines"), tooth disorder ("dental problems"), uterine leiomyoma ("hormonal changes describe: uterine fibroid next to left essure coil"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hyperacusis ("allergic or hypersensitivity reaction type: sound sensitivities"), photophobia ("allergic or hypersensitivity reaction type: light sensitivities"), food allergy ("allergic or hypersensitivity reaction type: food"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), streptococcal infection ("infection (other) describe: strep a"), peritonsillar abscess (seriousness criterion medically significant), epstein-barr virus infection ("infection (other); ebv"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia"), rash ("rashes or skin conditions type: rashes"), cyst ("reproductive system disorder or condition type of: cyst "), muscular weakness ("neurological conditions or problems type: muscle weakness"), reading disorder ("inability to read"), agraphia ("inability to write,"), allergy to metals ("nickel allergy"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), visual impairment ("vision/eye problems type: rapid deterioration of vision"), the second episode of fatigue ("fatigue"), weight decreased ("weight gain / loss specify which one: weight loss"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: gerd"), bladder disorder ("bladder or urinary problems or changes "), urinary tract disorder ("urinary tract disorder"), arthralgia ("hip pain"), sciatica ("sciatic pain") and dysgeusia ("metal tatse ").The patient was treated with surgery (she had surgery to remove the essure implant).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, pain, headache, dizziness, tinnitus, migraine, tooth disorder, uterine leiomyoma, hyperacusis, photophobia, food allergy, peritonsillar abscess, epstein-barr virus infection, anxiety, depression, fibromyalgia, rash, cyst, muscular weakness, reading disorder, agraphia, allergy to metals, dysmenorrhoea, vaginal discharge, visual impairment, the last episode of fatigue, weight decreased, bladder disorder, urinary tract disorder, arthralgia and sciatica outcome was unknown and the urinary tract infection, nausea, vaginal haemorrhage, menorrhagia, female sexual dysfunction and dysgeusia was resolving.The reporter provided no causality assessment for dizziness, headache, nausea, pain, tinnitus, urinary tract infection and the first episode of fatigue with essure.The reporter considered agraphia, allergy to metals, anxiety, arthralgia, bladder disorder, cyst, depression, dysgeusia, dysmenorrhoea, dyspareunia, epstein-barr virus infection, female sexual dysfunction, fibromyalgia, food allergy, gastrooesophageal reflux disease, hyperacusis, menorrhagia, migraine, muscular weakness, pelvic pain, peritonsillar abscess, photophobia, rash, reading disorder, sciatica, streptococcal infection, tooth disorder, urinary tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and the second episode of fatigue to be related to essure.The reporter commented: another expiration date for essure is nov-2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known possible undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.The technical assessment concluded ¿unconfirmed quality defect¿.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 20-jun-2018: plaintiff fact sheet received.Events uterine fibroid, vaginal bleeding, menorrhagia, food and sound/light sensitivities, uti, apareunia, strep a, peritonsillar abscess, ebv infection, anxiety, depression, fibromyalgia, rashes, migraines / headaches,cysts,dental problems,muscle weakness, inability to read/write, nickel allergy, dysmenorrhea (cramping), dyspareunia, vaginal discharge, rapid deterioration of vision, weight loss, gerd, hip pain , scitica pain, are added.Lot number & lab data updated.Historical & concomitant conditions drugs were added.Product, patient & reporter information updated.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
|
|
E was initially received via regulatory authority (food and drug administration, reference number: mw (b)(4)) on 24-sep-2014.The most recent information was received on 28-aug-2018.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain"), urinary tract infection ("utis / infection (bladder/ urinary tract/vaginal) type: uti (recurrent episodes),") and peritonsillar abscess ("infection: peritonsillar abscess") in a female patient who had essure (batch no.901325/919033) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included neck pain, spondylosis, arthroscopy, back pain, buttock pain, breast operation, knee operation and rhinoplasty.Previously administered products included for an unreported indication: birth control pill.Concurrent conditions included diarrhea, oral herpes, allergic rhinitis, attention deficit/hyperactivity disorder and fever.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced nausea ("nausea") and pain ("pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urinary tract infection (seriousness criterion medically significant), the first episode of fatigue ("chronic fatigue"), headache ("headaches"), dizziness ("dizziness"), tinnitus ("tinnitus"), migraine ("migraines"), tooth disorder ("dental problems"), uterine leiomyoma ("hormonal changes describe: uterine fibroid next to left essure coil"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hyperacusis ("allergic or hypersensitivity reaction type: sound sensitivities"), photophobia ("allergic or hypersensitivity reaction type: light sensitivities"), food allergy ("allergic or hypersensitivity reaction type: food"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), streptococcal infection ("infection (other) describe: strep a"), peritonsillar abscess (seriousness criterion medically significant), epstein-barr virus infection ("infection (other); ebv"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia"), rash ("rashes or skin conditions type: rashes"), cyst ("reproductive system disorder or condition type of: cyst "), muscular weakness ("neurological conditions or problems type: muscle weakness"), reading disorder ("inability to read"), agraphia ("inability to write,"), allergy to metals ("nickel allergy"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), visual impairment ("vision/eye problems type: rapid deterioration of vision"), the second episode of fatigue ("fatigue"), weight decreased ("weight gain / loss specify which one: weight loss"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: gerd"), bladder disorder ("bladder or urinary problems or changes "), urinary tract disorder ("urinary tract disorder"), arthralgia ("hip pain"), sciatica ("sciatic pain") and dysgeusia ("metal taste ").The patient was treated with surgery (she had surgery to remove the essure implant).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, pain, headache, dizziness, tinnitus, migraine, tooth disorder, uterine leiomyoma, hyperacusis, photophobia, food allergy, peritonsillar abscess, epstein-barr virus infection, anxiety, depression, fibromyalgia, rash, cyst, muscular weakness, reading disorder, agraphia, allergy to metals, dysmenorrhoea, vaginal discharge, visual impairment, the last episode of fatigue, weight decreased, bladder disorder, urinary tract disorder, arthralgia and sciatica outcome was unknown and the urinary tract infection, nausea, vaginal haemorrhage, menorrhagia, female sexual dysfunction and dysgeusia was resolving.The reporter provided no causality assessment for dizziness, headache, nausea, pain, tinnitus, urinary tract infection and the first episode of fatigue with essure.The reporter considered agraphia, allergy to metals, anxiety, arthralgia, bladder disorder, cyst, depression, dysgeusia, dysmenorrhoea, dyspareunia, epstein-barr virus infection, female sexual dysfunction, fibromyalgia, food allergy, gastrooesophageal reflux disease, hyperacusis, menorrhagia, migraine, muscular weakness, pelvic pain, peritonsillar abscess, photophobia, rash, reading disorder, sciatica, streptococcal infection, tooth disorder, urinary tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased and the second episode of fatigue to be related to essure.The reporter commented: another expiration date for essure is (b)(6) 2014.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion lot number: 901325, manufacture date: sep-2011, expiration date: sep-2014.Lot number: 919033, manufacture date: nov-2011, expiration date: nov-2014.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 28-aug-2018: quality-safety evaluation of product technical complaint.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 case was initially received via regulatory authority (food and drug administration, reference number: mw5037258) on 24-sep-2014.The most recent information was received on 26-nov-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pain'), urinary tract infection ('utis / infection (bladder/ urinary tract/vaginal) type: uti (recurrent episodes),') and peritonsillar abscess ('infection: peritonsillar abscess') in a 42-year-old female patient who had essure (batch no.901325/919033) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included neck pain, spondylosis, arthroscopy, back pain, buttock pain, breast operation, knee operation and rhinoplasty.Previously administered products included for an unreported indication: birth control pill.Concurrent conditions included diarrhea, oral herpes, allergic rhinitis, attention deficit/hyperactivity disorder and fever.Concomitant products included bupropion hydrochloride (wellbutrin).In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia") and gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: gerd").On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urinary tract infection (seriousness criterion medically significant), nausea ("nausea"), pain ("pain"), fatigue ("chronic fatigue"), headache ("headaches"), migraine ("migraines"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), hyperacusis ("allergic or hypersensitivity reaction type: sound sensitivities"), photophobia ("allergic or hypersensitivity reaction type: light sensitivities"), food allergy ("allergic or hypersensitivity reaction type: food"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), anxiety ("psychological or psychiatric problems condition: anxiety"), rash ("rashes or skin conditions type: rashes"), muscular weakness ("neurological conditions or problems type: muscle weakness"), vaginal discharge ("vaginal discharge"), bladder disorder ("bladder or urinary problems or changes") and urinary tract disorder ("urinary tract disorder") and was found to have uterine leiomyoma ("hormonal changes describe: uterine fibroid next to left essure coil") and weight decreased ("weight gain / loss specify which one: weight loss").In 2013, the patient experienced dental caries ("dental problems"), fibromyalgia ("autoimmune disorder type of disorder: fibromyalgia") and visual impairment ("vision/eye problems type: rapid deterioration of vision").In (b)(6) 2014, the patient experienced streptococcal infection ("infection (other) describe: strep a"), peritonsillar abscess (seriousness criterion medically significant) and epstein-barr virus infection ("infection (other); ebv").On an unknown date, the patient experienced allergy to metals ("nickel allergy"), 8 months 24 days after insertion of essure.On an unknown date, the patient experienced dizziness ("dizziness"), the first episode of tinnitus ("tinnitus"), depression ("psychological or psychiatric problems condition: depression"), cyst ("reproductive system disorder or condition type of: cyst/kidney cyst/ femur cyst"), reading disorder ("inability to read"), agraphia ("inability to write,"), arthralgia ("hip pain"), sciatica ("sciatic pain"), dysgeusia ("metal tatse"), abdominal pain ("abdominal pain"), back pain ("back pain"), pruritus ("itchy scalp together with essure"), dry eye ("hoping explant help dry eye issue"), costochondritis ("costochondritis"), rib deformity ("rib cage deformity"), gastrointestinal disorder ("gi issues"), pain in extremity ("leg pain"), contusion ("i had dark bruises"), fungal infection ("yeast infection"), libido decreased ("decrease libido"), miller fisher syndrome ("fish hook syndrome"), pilonidal cyst ("pilonidal cyst too"), glaucoma ("high risk glaucoma"), the second episode of tinnitus ("tinnitus") and post procedural haemorrhage ("spotting and bleeding post procedure").The patient was treated with antibiotics and surgery (hysterectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, pain, fatigue, dizziness, dental caries, uterine leiomyoma, hyperacusis, photophobia, food allergy, peritonsillar abscess, epstein-barr virus infection, anxiety, depression, fibromyalgia, rash, cyst, muscular weakness, reading disorder, agraphia, dysmenorrhoea, vaginal discharge, visual impairment, weight decreased, bladder disorder, urinary tract disorder, arthralgia, sciatica, abdominal pain, back pain, pruritus, dry eye, costochondritis, rib deformity, pain in extremity, contusion, libido decreased, miller fisher syndrome, pilonidal cyst, the last episode of tinnitus and post procedural haemorrhage outcome was unknown, the urinary tract infection, nausea, headache, migraine, vaginal haemorrhage, menorrhagia, female sexual dysfunction, gastrooesophageal reflux disease and dysgeusia was resolving and the allergy to metals and gastrointestinal disorder had resolved.The reporter considered abdominal pain, agraphia, allergy to metals, anxiety, arthralgia, back pain, bladder disorder, contusion, costochondritis, cyst, dental caries, depression, dizziness, dry eye, dysgeusia, dysmenorrhoea, dyspareunia, epstein-barr virus infection, fatigue, female sexual dysfunction, fibromyalgia, food allergy, fungal infection, gastrointestinal disorder, gastrooesophageal reflux disease, glaucoma, headache, hyperacusis, libido decreased, menorrhagia, migraine, miller fisher syndrome, muscular weakness, nausea, pain, pain in extremity, pelvic pain, peritonsillar abscess, photophobia, pilonidal cyst, post procedural haemorrhage, pruritus, rash, reading disorder, rib deformity, sciatica, streptococcal infection, urinary tract disorder, urinary tract infection, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, visual impairment, weight decreased, the first episode of tinnitus and the second episode of tinnitus to be related to essure.The reporter commented: another expiration date for essure is (b)(6) 2014.Current weight: 125 lbs diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Lot number: 901325 manufacture date: sep-2011 expiration date: sep-2014.Lot number: 919033 manufacture date: nov-2011 expiration date: nov-2014.Concerning the injuries reported in this case, the following one was reported via social media: leg pain, bruises, yeast infection, lower libido, miller fisher syndrome, pilonidal cyst, glaucoma and tooth decay.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 26-nov-2019: fu 8,9 and 10 processed together.Social media received- new event abdominal pain, back pain, pruritus, dry eye, costochondritis, rib deformity, gastrointestinal disorder, tinnitus and post procedural bleeding were added.Reporter information was added.On 26-nov-2019: fu 8,9 and 10 processed together.Social media received- new event leg pain, bruises, yeast infection, lower libido, miller fisher syndrome, pilonidal cyst, glaucoma were added.Pt of the event tooth disorder was updated to tooth decay.On 2-dec-2019: fu 8,9 and 10 processed together.No new significant information was added.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.
|
| |
|
Search Alerts/Recalls
|
|
