| Model Number ESS305 |
| Device Problems
Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
| Patient Problems
Menstrual Irregularities (1959); Pain (1994); Uterine Perforation (2121); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); No Clinical Signs, Symptoms or Conditions (4582)
|
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("left device was protruding from the left fallopian tube") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), pelvic pain ("chronic pelvic pain,"), dyspareunia ("pain during intercourse") and menorrhagia ("excessive and abnormal bleeding during menstruation").The patient was treated with surgery (underwent a laparoscopy, bilateral salpingectomy and removal of the left device).At the time of the report, the fallopian tube perforation, pelvic pain, dyspareunia and menorrhagia outcome was unknown.The reporter considered dyspareunia, fallopian tube perforation, menorrhagia and pelvic pain to be related to essure.Diagnostic results: on an unspecified date patient had , performed ultrasound showed that the left device was protruding from the left fallopian tube.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
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("left device was protruding from the left fallopian tube\malposition of essure device location of device: left coil protruding through located cornual stump"), device dislocation ("migration of essure device location of device: unknown , right coil not located\ malposition of essure device- location of device; right essure is not visualized") and embedded device ("the left essure coil seems to be embedded into the myometrium and through to the serosa") in a 34-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: on an unspecified date patient had , performed ultrasound showed that the left device was protruding from the left fallopian tube.Concurrent conditions included body mass index normal, vomiting, ovarian cyst, abdominal pain, knee pain since (b)(6) 2013, bursitis since (b)(6) 2013, gi irritation since (b)(6) 2014, diarrhea since (b)(6) 2014, stomach pain since (b)(6) 2014, appetite disorder since (b)(6) 2014, flank pain since (b)(6) 2014, lower abdominal pain since (b)(6) 2014, hemorrhoids since (b)(6) 2014, throbbing pain, bowel movement irregularity since (b)(6) 2014, left lower quadrant pain since (b)(6) 2014, tooth pain since (b)(6) 2014, tooth fracture since (b)(6) 2014, periumbilical pain since (b)(6) 2014, acute gastroenteritis since (b)(6) 2014, acute gingivitis, uterine bleeding, vulval pruritus, genital bleeding, vulval itching and vaginal discharge.Concomitant products included citalopram since (b)(6) 2016, docusate sodium (colace) since (b)(6) 2014, ondansetron (zofran) since (b)(6) 2014 and venlafaxine since (b)(6) 2016.In (b)(6) 2013, the patient experienced pelvic pain ("chronic pelvic pain\pain") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced menorrhagia ("excessive and abnormal bleeding during menstruation"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines") and headache ("headaches").In december 2013, the patient experienced anxiety ("psychological or psychiatric problems condition: anxiety/depression"), depression ("psychological or psychiatric problems condition: anxiety/depression"), nausea ("nausea") and fatigue ("fatigue").In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse\dyspareunia (painfulsexual intercourse)").In (b)(6) 2014, the patient experienced constipation ("gastrointestinal or digestive system condition type: constipation").In (b)(6) 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2015, the patient experienced tooth disorder ("dental problems").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2015, the patient experienced visual impairment ("vision/eye problems type: vision problems").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) and vulvovaginal pain ("vagina pain").The patient was treated with celecoxib (celexa), codeine phosphate;paracetamol (tylenol with codeine no.3), ibuprofen (midol cramp), ibuprofen (motrin migraine pain), lorazepam, lorazepam (ativan), sertraline hydrochloride (zoloft), venlafaxine hydrochloride (effexor) and surgery (operative laparoscopy, bilateral salpingectomy, removal of left essure device.Endometrial biopsy).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device dislocation, embedded device, menorrhagia, vaginal haemorrhage, headache, visual impairment and fatigue outcome was unknown, the pelvic pain, dyspareunia, female sexual dysfunction, anxiety, depression, migraine, dysmenorrhoea, vaginal discharge, constipation and vulvovaginal pain was resolving and the nausea and tooth disorder had resolved.The reporter considered anxiety, constipation, depression, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, female sexual dysfunction, headache, menorrhagia, migraine, nausea, pelvic pain, tooth disorder, vaginal discharge, vaginal haemorrhage, visual impairment and vulvovaginal pain to be related to essure.The reporter commented: current weight 124 lbs.As per pfs (removal surgery information) "right essure coil was never removed or found.Physician informed that it would be dangerous to look for the coil than to just "let it be." diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.8 kg/sqm.Computerised tomogram abdomen - on (b)(6) 2014: impression: probable partial left ovarian cyst rupture.Hysterosalpingogram - on (b)(6) 2013: result: total bilateral occlusion.Effective essure occlusion.Ultrasound scan vagina - on (b)(6) 2014: impression: cystic changes are seen in the left ovary.A small amount of free fluid is seen in the cul-de-sac.Concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, anxiety, constipation, vaginal discharge, dyspareunia.Most recent follow-up information incorporated above includes: on 29-jan-2019: pfs received; reporters were added.Reporter's demographics were added.Events- abnormal bleeding (vaginal), apareunia (inability to have sexual intercourse), psychological or psychiatric problems condition: anxiety/depression, malposition of essure device location of device: left coil protruding through located corneal stump; right coil not, migraines / headaches, migration of essure device location of device: unknown;right coil not located, nausea, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pain, vaginal discharge, vision/eye problems type: vision problems, fatigue, gastrointestinal or digestive system condition type: constipation, device embedded (captured from mr) were added.Treatment drugs were added.Concomitant drugs were added.Concomitant condition were added.Auto narrative was added.Reporter causality comments was added.Outcomes- was added.Lab tests were added.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('left device was protruding from the left fallopian tube\malposition of essure device location of device: left coil protruding through located cornual stump'), device dislocation ('migration of essure device location of device: unknown , right coil not located\ malposition of essure device- location of device; right essure is not visualized/ riht device not located') and embedded device ('the left essure coil seems to be embedded into the myometrium and through to the serosa') in a 34-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: * on an unspecified date patient had , performed ultrasound showed that the left device was protruding from the left fallopian tube.Concurrent conditions included acute gastroenteritis since (b)(6) 2014, left lower quadrant pain since (b)(6) 2014, tooth pain since (b)(6) 2014, tooth fracture since (b)(6) 2014, periumbilical pain since (b)(6) 2014, flank pain since (b)(6) 2014, lower abdominal pain since (b)(6) 2014, hemorrhoids since (b)(6) 2014, bowel movement irregularity since (b)(6) 2014, gi irritation since (b)(6) 2014, diarrhea since (b)(6) 2014, stomach pain since (b)(6) 2014, appetite disorder since (b)(6) 2014, knee pain since (b)(6) 2013, bursitis since (b)(6) 2013, body mass index normal, vomiting, ovarian cyst, abdominal pain, throbbing pain, acute gingivitis, uterine bleeding, vulval pruritus, genital bleeding, vulval itching and vaginal discharge.Concomitant products included citalopram since (b)(6) 2016, docusate sodium (colace) since (b)(6) 2014, ondansetron (zofran) since (b)(6) 2014 and venlafaxine since (b)(6) 2016.In (b)(6) 2013, the patient experienced pelvic pain ("chronic pelvic pain\pain") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2013, the patient experienced the first episode of depression ("psychological or psychiatric problems condition: anxiety/depression"), the second episode of depression ("psychological or psychiatric problems condition: anxiety/depression"), nausea ("nausea") and fatigue ("fatigue").In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse\dyspareunia (painfulsexual intercourse)").In (b)(6) 2014, the patient experienced constipation ("gastrointestinal or digestive system condition type: constipation").In (b)(6) 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2015, the patient experienced tooth disorder ("dental problems").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2015, the patient experienced visual impairment ("vision/eye problems type: vision problems").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) and vulvovaginal pain ("vagina pain").The patient was treated with celecoxib (celexa), ibuprofen (midol cramp), ibuprofen (motrin migraine pain), lorazepam, lorazepam (ativan), paracetamol (tylenol), sertraline hydrochloride (zoloft), venlafaxine hydrochloride (effexor) and surgery (total hysterectomy; bilateral salpingectomy, removal of left essure device.Endometrial biopsy).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device dislocation, embedded device, heavy menstrual bleeding, vaginal haemorrhage, headache, visual impairment and fatigue outcome was unknown, the pelvic pain, dyspareunia, female sexual dysfunction, the last episode of depression, migraine, dysmenorrhoea, vaginal discharge, constipation and vulvovaginal pain was resolving and the nausea and tooth disorder had resolved.The reporter considered constipation, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, female sexual dysfunction, headache, heavy menstrual bleeding, migraine, nausea, pelvic pain, tooth disorder, vaginal discharge, vaginal haemorrhage, visual impairment, vulvovaginal pain, the first episode of depression and the second episode of depression to be related to essure.The reporter commented: current weight 124 lbs.As per pfs (removal surgery information) "right essure coil was never removed or found.Physician informed that it would be dangerous to look for the coil than to just "let it be." discrepancy noted in date of removal- (b)(6) 2019.The right fallopian tube stump is 1.7cm in length and 0.3cm in diameter.On cut section, there is a tightly embedded metallic coil within the fallopian tube lumen with the coil tip slightly protruding at the distal end.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.8 kg/sqm.Computerised tomogram abdomen - on (b)(6) 2014: impression: probable partial left ovarian cyst rupture.Hysterosalpingogram - on (b)(6) 2013: result: total bilateral occlusion.Effective essure occlusion.Ultrasound scan vagina - on (b)(6) 2014: impression: cystic changes are seen in the left ovary.A small amount of free fluid is seen in the cul-de-sac.¿concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, anxiety, constipation, vaginal discharge, dyspareunia.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 18-may-2021: quality safety evaluation of ptc.Incident: based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('left device was protruding from the left fallopian tube\malposition of essure device location of device: left coil protruding through located cornual stump'), device dislocation ('migration of essure device location of device: unknown , right coil not located\ malposition of essure device- location of device; right essure is not visualized/ riht device not located') and embedded device ('the left essure coil seems to be embedded into the myometrium and through to the serosa') in a 34-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: * on an unspecified date patient had , performed ultrasound showed that the left device was protruding from the left fallopian tube.Concurrent conditions included acute gastroenteritis since (b)(6) 2014, left lower quadrant pain since (b)(6) 2014, tooth pain since (b)(6) 2014, tooth fracture since (b)(6)2014, periumbilical pain since (b)(6) 2014, flank pain since (b)(6) 2014, lower abdominal pain since (b)(6) 2014, hemorrhoids since (b)(6) 2014, bowel movement irregularity since (b)(6) 2014, gi irritation since (b)(6) 2014, diarrhea since (b)(6) 2014, stomach pain since (b)(6) 2014, appetite disorder since (b)(6) 2014, knee pain since (b)(6) 2013, bursitis since (b)(6) 2013, body mass index normal, vomiting, ovarian cyst, abdominal pain, throbbing pain, acute gingivitis, uterine bleeding, vulval pruritus, genital bleeding, vulval itching and vaginal discharge.Concomitant products included citalopram since (b)(6) 2016, docusate sodium (colace) since (b)(6) 2014, ondansetron (zofran) since (b)(6) 2014 and venlafaxine since (b)(6) 2016.In (b)(6) 2013, the patient experienced pelvic pain ("chronic pelvic pain\pain") and dysmenorrhoea ("dysmenorrhea(cramping)").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2013, the patient experienced the first episode of depression ("psychological or psychiatric problems condition: anxiety/depression"), the second episode of depression ("psychological or psychiatric problems condition: anxiety/depression"), nausea ("nausea") and fatigue ("fatigue").In (b)(6) 2014, the patient experienced dyspareunia ("pain during intercourse\dyspareunia (painfulsexual intercourse)").In (b)(6) 2014, the patient experienced constipation ("gastrointestinal or digestive system condition type: constipation").In (b)(6) 2014, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In (b)(6) 2015, the patient experienced tooth disorder ("dental problems").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In (b)(6) 2015, the patient experienced visual impairment ("vision/eye problems type: vision problems").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) and vulvovaginal pain ("vagina pain").The patient was treated with celecoxib (celexa), ibuprofen (midol cramp), ibuprofen (motrin migraine pain), lorazepam, lorazepam (ativan), paracetamol (tylenol), sertraline hydrochloride (zoloft), venlafaxine hydrochloride (effexor) and surgery (total hysterectomy; bilateral salpingectomy, removal of left essure device.Endometrial biopsy).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device dislocation, embedded device, heavy menstrual bleeding, vaginal haemorrhage, headache, visual impairment and fatigue outcome was unknown, the pelvic pain, dyspareunia, female sexual dysfunction, the last episode of depression, migraine, dysmenorrhoea, vaginal discharge, constipation and vulvovaginal pain was resolving and the nausea and tooth disorder had resolved.The reporter considered constipation, device dislocation, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, female sexual dysfunction, headache, heavy menstrual bleeding, migraine, nausea, pelvic pain, tooth disorder, vaginal discharge, vaginal haemorrhage, visual impairment, vulvovaginal pain, the first episode of depression and the second episode of depression to be related to essure.The reporter commented: current weight 124 lbs.As per pfs (removal surgery information) "right essure coil was never removed or found.Physician informed that it would be dangerous to look for the coil than to just "let it be." discrepancy noted in date of removal- (b)(6) 2019.The right fallopian tube stump is 1.7cm in length and 0.3cm in diameter.On cut section, there is a tightly embedded metallic coil within the fallopian tube lumen with the coil tip slightly protruding at the distal end.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 22.8 kg/sqm.Computerised tomogram abdomen - on (b)(6) 2014: impression: probable partial left ovarian cyst rupture.Hysterosalpingogram - on (b)(6) 2013: result: total bilateral occlusion.Effective essure occlusion.Ultrasound scan vagina - on (b)(6) 2014: impression: cystic changes are seen in the left ovary.A small amount of free fluid is seen in the cul-de-sac.¿concerning the injuries reported in this case, the following ones were described in patients medical record: nausea, anxiety, constipation, vaginal discharge, dyspareunia.Most recent follow-up information incorporated above includes: on 26-apr-2021: mr received.No new clinical information added.Incident: based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
