| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Increased Sensitivity (2065)
|
| Event Date 11/01/2014 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction").The patient was treated with surgery (underwent a total hysterectomy due to complications from the essure).At the time of the report, the pelvic pain, menstrual disorder and hypersensitivity outcome was unknown.The reporter considered hypersensitivity, menstrual disorder and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: confirming essure device was successfully occluded.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
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").In (b)(6) 2014, the patient experienced abdominal pain lower ("left lower quadrant pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction").The patient was treated with surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menstrual disorder, hypersensitivity, menorrhagia, abdominal pain lower and vaginal haemorrhage outcome was unknown.The reporter considered abdominal pain lower, hypersensitivity, menorrhagia, menstrual disorder, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: confirming essure device was successfully occluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received and the following information was provided: essure removal date and lot number c76447; abnormal bleeding (vaginal, menorrhagia) and left lower quadrant pain were added as event.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") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3.Concurrent conditions included headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6) 2015, pain in arm since (b)(6) 2015, dysgeusia, pain legs since 15-nov-2016, smoker, alcohol use and caffeine consumption.In october 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On 29-oct-2014, the patient had essure inserted.In november 2014, the patient experienced abdominal pain lower ("left lower quadrant pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction").The patient was treated with surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on 28-dec-2016.At the time of the report, the pelvic pain, uterine haemorrhage, menstrual disorder, hypersensitivity, menorrhagia, abdominal pain lower and vaginal haemorrhage outcome was unknown.The reporter considered abdominal pain lower, hypersensitivity, menorrhagia, menstrual disorder, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 29-jan-2015: confirming essure device was successfully occluded concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain most recent follow-up information incorporated above includes: on 1-mar-2018: mr received: new reporters, concomitant disease and new event uterine haemorrhage 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
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3.Concurrent conditions included headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6)2015, pain in arm since (b)(6) 2015, dysgeusia, pain legs since (b)(6) 2016, smoker, alcohol use and caffeine consumption.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("left lower quadrant pain").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues"), hypersensitivity ("allergic reaction") and fatigue ("fatigue").The patient was treated with surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the uterine haemorrhage, pelvic pain, menorrhagia, vaginal haemorrhage, migraine and fatigue had resolved and the , menstrual disorder, hypersensitivity, abdominal pain lower and headache outcome was unknown.The reporter considered abdominal pain lower, fatigue, headache, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.The reporter commented: essure was removed due to adverse events.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: confirming essure device was successfully occluded concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received and the following information was provided: migraines, headaches, fatigue were added as event; events outcome 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
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3.Concurrent conditions included headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6) 2015, pain in arm since (b)(6) 2015, dysgeusia, pain legs since (b)(6) 2016, smoker, alcohol use and caffeine consumption.In 2014, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("left lower quadrant pain").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues"), hypersensitivity ("allergic reaction") and fatigue ("fatigue").The patient was treated with surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, menorrhagia, vaginal haemorrhage, migraine and fatigue had resolved and the menstrual disorder, hypersensitivity, abdominal pain lower and headache outcome was unknown.The reporter considered abdominal pain lower, fatigue, headache, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.The reporter commented: essure was removed due to adverse events.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: confirming essure device was successfully occluded.Concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jul-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
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3.Concurrent conditions included headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6) 2015, pain in arm since(b)(6) 2015, dysgeusia, pain legs since (b)(6) 2016, smoker, alcohol use and caffeine consumption.Concomitant products included cilest (ortho tri-cyclen) from (b)(6) 2014 to (b)(6) 2014.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("left lower quadrant pain").In (b)(6) 2015, the patient experienced migraine ("migraines"), headache ("headaches"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues"), hypersensitivity ("allergic reaction"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, menorrhagia, vaginal haemorrhage, migraine and fatigue had resolved and the menstrual disorder, hypersensitivity, abdominal pain lower, headache, depression and anxiety outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, fatigue, headache, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.The reporter commented: essure was removed due to adverse events.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 29-jan-2015: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-aug-2018: plaintiff fact sheet received, events: psychological or psychiatric problems condition: depression and mental anguish added, event onset date updated, concomitant drug added, reporter details were 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
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain/pelvic pain') and uterine haemorrhage ('abnormal uterine bleeding') in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida and parity 3.Previously administered products included for an unreported indication: famotidine from (b)(6) 2013 to (b)(6) 2013.Concurrent conditions included pain legs since (b)(6) 2016, pain in arm since (b)(6) 2015, headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6) 2015, dysgeusia, smoker, alcohol use and caffeine consumption.Concomitant products included ethinylestradiol;levonorgestrel (levonorgestrel + etinilestradiol) from (b)(6) 2014 to (b)(6) 2015, ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2013 to (b)(6) 2015, ibuprofen in 2014, norethisterone (micronor) from (b)(6) 2015 to (b)(6) 2017 and paracetamol (acetaminophen) in 2014.In 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)/abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression/psychological or psychiatric problems condition: depression and mental anguish") and anxiety ("psychological or psychiatric problems condition: mental anguish/psychological or psychiatric problems condition: mental anguish").On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("left lower quadrant pain").In (b)(6) 2015, the patient experienced migraine ("migraines/migraine/headache"), headache ("headaches/migraine/headache") and fatigue ("fatigue/fatigue").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction").The patient was treated with alprazolam and surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, hypersensitivity, menorrhagia, abdominal pain lower, vaginal haemorrhage, migraine and fatigue had resolved and the menstrual disorder, headache, depression and anxiety outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, fatigue, headache, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.The reporter commented: essure was removed due to adverse events.Discrepancy noted in essure removal: if you have not had your essure removed, are you currently planning for essure removal? :no patient received treatment for pain, bleeding and allergic reaction.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: plaintiff fact sheet was received.Outcome of events left lower quadrant pain and allergic reaction was updated to recovered/resolved.Reporter causality comment 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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain/pelvic pain') and uterine haemorrhage ('abnormal uterine bleeding') in an adult female patient who had essure (batch no.C76447) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida and parity 3.Previously administered products included for an unreported indication: famotidine from (b)(6) 2013 to (b)(6) 2013.Concurrent conditions included pain legs since (b)(6) 2016, pain in arm since (b)(6) 2015, headache since (b)(6) 2015, fatigue since (b)(6) 2015, foot pain since (b)(6) 2015, dysgeusia, smoker, alcohol use and caffeine consumption.Concomitant products included ethinylestradiol;levonorgestrel (levonorgestrel + etinilestradiol) from (b)(6) 2014 to (b)(6) 2015, ethinylestradiol;norgestimate (ortho tri-cyclen) from (b)(6) 2013 to (b)(6) 2015, ibuprofen in 2014, norethisterone (micronor) from (b)(6) 2015 to (b)(6) 2017 and paracetamol (acetaminophen) in 2014.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)/abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)/abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression/psychological or psychiatric problems condition: depression and mental anguish") and anxiety ("psychological or psychiatric problems condition: mental anguish/psychological or psychiatric problems condition: mental anguish").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("left lower quadrant pain").In january 2015, the patient experienced migraine ("migraines/migraine/headache"), headache ("headaches/migraine/headache") and fatigue ("fatigue/fatigue").On an unknown date, the patient experienced uterine haemorrhage (seriousness criterion medically significant), menstrual disorder ("persistent menstruation issues") and hypersensitivity ("allergic reaction").The patient was treated with alprazolam and surgery (underwent a total hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, hypersensitivity, menorrhagia, abdominal pain lower, vaginal haemorrhage, migraine and fatigue had resolved and the menstrual disorder, headache, depression and anxiety outcome was unknown.The reporter considered abdominal pain lower, anxiety, depression, fatigue, headache, hypersensitivity, menorrhagia, menstrual disorder, migraine, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure.The reporter commented: essure was removed due to adverse events.Discrepancy noted in essure removal: if you have not had your essure removed, are you currently planning for essure removal? :no patient received treatment for pain, bleeding and allergic reaction.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: total bilateral occlusion.Concerning the injuries in the case, the following ones were described in patient's medical records: uterine haemorrhage (confirming vaginal haemorrhage), abdominal pain, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jun-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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
|
|
