| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Vomiting (2144); Depression (2361); Weight Changes (2607); Heavier Menses (2666)
|
| Event Date 03/01/2009 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of dyspareunia ("pain during intercourse"), pelvic pain ("pelvic pain"), uterine leiomyoma ("uterine fibroids"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia") and genital haemorrhage ("heavy bleeding") in a (b)(6) female patient who had essure (batch no.628048) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included oxycocet (percocet).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("abdominal pain").In (b)(6) 2009, the patient experienced weight fluctuation ("weight fluctuation / weight gain and loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and back pain ("back pain").In (b)(6) 2012, the patient experienced dyspareunia (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting").In (b)(6) 2016, the patient experienced vaginal discharge ("vaginal discharge").In 2017, the patient experienced uterine leiomyoma (seriousness criterion medically significant).In (b)(6) 2017, the patient experienced dysmenorrhoea ("severe menstrual pain").On an unknown date, the patient experienced depression ("depression"), fatigue ("fatigue"), anaemia ("anemia") and iron deficiency anaemia ("iron deficiency anemia").The patient was treated with iron, anovlar (microgestin) and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the dyspareunia, pelvic pain, dysmenorrhoea, abdominal pain, back pain, anaemia, nausea, vaginal discharge and vomiting had resolved, the uterine leiomyoma, vaginal haemorrhage, menorrhagia, genital haemorrhage, fatigue and iron deficiency anaemia outcome was unknown and the depression, alopecia and weight fluctuation was resolving.The reporter considered abdominal pain, alopecia, anaemia, back pain, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vomiting and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2017: total abdominal hysterectomy with bilateral salpingectomies: postoperative diagnoses: symptomatic uterine fibroids.Chronic pelvic pain.Menorrhagia.Dyspareunia.Chronic anemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2009: confirmed that fallopian tubes were fully occluded ultrasound scan - on an unknown date: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, genital bleeding, menorrhagia, iron deficiency anemia, weight loss, uterine leiomyoma, dysmenorrhea, dyspareunia most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs and mr received.Lot number provided (628048).Events added: vaginal bleeding, menorrhagia, anemia, nausea, vaginal discharge, hair loss, vomiting, iron deficiency anemia.It was reported that on (b)(6) 2017 hysterectomy with bilateral salpingectomy was performed.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 dyspareunia ("pain during intercourse"), pelvic pain ("pelvic pain"), uterine leiomyoma ("uterine fibroids"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia") and genital haemorrhage ("heavy bleeding") in a 39-year-old female patient who had essure (batch no.628048) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included oxycocet (percocet).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("abdominal pain").In (b)(6) 2009, the patient experienced weight fluctuation ("weight fluctuation / weight gain and loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and back pain ("back pain").In (b)(6) 2012, the patient experienced dyspareunia (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting").In (b)(6) 2016, the patient experienced vaginal discharge ("vaginal discharge").In 2017, the patient experienced uterine leiomyoma (seriousness criterion medically significant).In (b)(6) 2017, the patient experienced dysmenorrhoea ("severe menstrual pain").On an unknown date, the patient experienced depression ("depression"), fatigue ("fatigue"), anaemia ("anemia") and iron deficiency anaemia ("iron deficiency anemia").The patient was treated with iron, anovlar (microgestin), surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the dyspareunia, pelvic pain, dysmenorrhoea, abdominal pain, back pain, anaemia, nausea, vaginal discharge and vomiting had resolved, the uterine leiomyoma, vaginal haemorrhage, menorrhagia, genital haemorrhage, fatigue and iron deficiency anaemia outcome was unknown and the depression, alopecia and weight fluctuation was resolving.The reporter considered abdominal pain, alopecia, anaemia, back pain, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vomiting and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2017: total abdominal hysterectomy with bilateral.Salpingectomies: postoperative diagnoses: symptomatic uterine fibroids.Chronic pelvic pain.Menorrhagia.Dyspareunia.Chronic anemia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2009: confirmed that fallopian tubes were fully occluded.Ultrasound scan - on an unknown date: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, genital bleeding, menorrhagia, iron deficiency anemia, weight loss, uterine leiomyoma, dysmenorrhea, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-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 dyspareunia ('pain during intercourse'), pelvic pain ('pelvic pain'), uterine leiomyoma ('uterine fibroids'), vaginal haemorrhage ('vaginal bleeding'), menorrhagia ('menorrhagia') and genital haemorrhage ('heavy bleeding') in a 39-year-old female patient who had essure (batch no.628048) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight and hypertension.Concomitant products included oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced depression ("depression").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain") and back pain ("back pain").In (b)(6) 2009, the patient experienced weight fluctuation ("weight fluctuation / weight gain and loss/ both weight gain and loss").In (b)(6) 2012, the patient experienced dyspareunia (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In 2017, the patient was found to have uterine leiomyoma (seriousness criterion medically significant).In (b)(6) 2017, the patient experienced dysmenorrhoea ("severe menstrual pain"), reproductive tract disorder ("reproductive system disorder or condition"), blood disorder ("blood or heart disorder") and cardiac disorder ("blood or heart disorder").On an unknown date, the patient experienced fatigue ("fatigue"), anaemia ("anemia") and iron deficiency anaemia ("iron deficiency anemia").The patient was treated with ethinylestradiol;norethisterone acetate (microgestin), iron and surgery (hysterectomy with bilateral salpingectomy and hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the dyspareunia, pelvic pain, dysmenorrhoea, abdominal pain, back pain, depression, anaemia, nausea, vaginal discharge, alopecia, vomiting and weight fluctuation had resolved and the uterine leiomyoma, vaginal haemorrhage, menorrhagia, genital haemorrhage, fatigue, iron deficiency anaemia, reproductive tract disorder, blood disorder and cardiac disorder outcome was unknown.The reporter considered abdominal pain, alopecia, anaemia, back pain, blood disorder, cardiac disorder, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, reproductive tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vomiting and weight fluctuation to be related to essure.The reporter commented: on (b)(6) 2017: total abdominal hysterectomy with bilateral salpingectomies: postoperative diagnoses: 1.Symptomatic uterine fibroids.2.Chronic pelvic pain.3.Menorrhagia.4.Dyspareunia.5.Chronic anemia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: results: confirmed that fallopian tubes were fully occluded.Ultrasound scan - on an unknown date: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, genital bleeding, menorrhagia, iron deficiency anemia, weight loss, uterine leiomyoma, dysmenorrhea, dyspareunia quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 23-dec-2019: plaintiff fact sheet received.Events per pfs: reproductive system disorder or condition and blood or heart disorder.Outcome for weight fluctuations, hair loss and depression were resolved.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 dyspareunia ('pain during intercourse/ dyspareunia'), pelvic pain ('pelvic pain, few times evert month/ pain'), uterine leiomyoma ('uterine fibroids'), vaginal haemorrhage ('vaginal bleeding'), menorrhagia ('menorrhagia') and genital haemorrhage ('heavy bleeding/ abnormal bleeding') in a 39-year-old female patient who had essure (batch no.628048) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight and hypertension.Concomitant products included oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced depression ("depression").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain/ dysmenorrhoea "), abdominal pain ("abdominal pain") and back pain ("back pain").In (b)(6) 2009, the patient experienced weight fluctuation ("weight fluctuation / weight gain and loss/ both weight gain and loss").In (b)(6) 2012, the patient experienced dyspareunia (seriousness criteria medically significant and intervention required).In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In 2017, the patient was found to have uterine leiomyoma (seriousness criterion medically significant).In (b)(6) 2017, the patient experienced reproductive tract disorder ("reproductive system disorder or condition"), blood disorder ("blood or heart disorder") and cardiac disorder ("blood or heart disorder").On an unknown date, the patient experienced fatigue ("fatigue"), anaemia ("anemia") and iron deficiency anaemia ("iron deficiency anemia") and was found to have weight increased ("weight gain").The patient was treated with ethinylestradiol;norethisterone acetate (microgestin), iron and surgery (hysterectomy with bilateral salpingectomy, hysterectomy and hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the dyspareunia, pelvic pain, dysmenorrhoea, abdominal pain, back pain, depression, anaemia, nausea, vaginal discharge, alopecia, vomiting and weight fluctuation had resolved and the uterine leiomyoma, vaginal haemorrhage, menorrhagia, genital haemorrhage, fatigue, iron deficiency anaemia, reproductive tract disorder, blood disorder, cardiac disorder and weight increased outcome was unknown.The reporter considered abdominal pain, alopecia, anaemia, back pain, blood disorder, cardiac disorder, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, reproductive tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vomiting, weight fluctuation and weight increased to be related to essure.The reporter commented: on (b)(6) 2017: total abdominal hysterectomy with bilateral salpingectomies: postoperative diagnoses: 1.Symptomatic uterine fibroids.2.Chronic pelvic pain.3.Menorrhagia.4.Dyspareunia.5.Chronic anemia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: results: confirmed that fallopian tubes were fully occluded.Ultrasound scan - on an unknown date: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-aug-2020: pif received.Event added: weight gain.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 ('pelvic pain, few times evert month/ pain'), dyspareunia ('pain during intercourse/ dyspareunia'), vaginal haemorrhage ('vaginal bleeding'), menorrhagia ('menorrhagia'), genital haemorrhage ('heavy bleeding/ abnormal bleeding') and uterine leiomyoma ('uterine fibroids') in a 39-year-old female patient who had essure (batch no.628048) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight and hypertension.Concomitant products included oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced depression ("depression").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain/ dysmenorrhoea "), abdominal pain ("abdominal pain") and back pain ("back pain").In (b)(6) 2009, the patient experienced weight fluctuation ("weight fluctuation / weight gain and loss/ both weight gain and loss").In (b)(6) 2012, the patient experienced dyspareunia (seriousness criteria medically significant and intervention required).In june 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting").In (b)(6) 2015, the patient experienced vaginal discharge ("vaginal discharge").In 2017, the patient was found to have uterine leiomyoma (seriousness criterion medically significant).In july 2017, the patient experienced reproductive tract disorder ("reproductive system disorder or condition"), blood disorder ("blood or heart disorder") and cardiac disorder ("blood or heart disorder").On an unknown date, the patient experienced fatigue ("fatigue"), anaemia ("anemia") and iron deficiency anaemia ("iron deficiency anemia") and was found to have weight increased ("weight gain").The patient was treated with ethinylestradiol;norethisterone acetate (microgestin), iron and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dyspareunia, dysmenorrhoea, abdominal pain, back pain, depression, anaemia, nausea, vaginal discharge, alopecia, vomiting and weight fluctuation had resolved and the vaginal haemorrhage, menorrhagia, genital haemorrhage, uterine leiomyoma, fatigue, iron deficiency anaemia, reproductive tract disorder, blood disorder, cardiac disorder and weight increased outcome was unknown.The reporter considered abdominal pain, alopecia, anaemia, back pain, blood disorder, cardiac disorder, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, iron deficiency anaemia, menorrhagia, nausea, pelvic pain, reproductive tract disorder, uterine leiomyoma, vaginal discharge, vaginal haemorrhage, vomiting, weight fluctuation and weight increased to be related to essure.The reporter commented: on (b)(6) 2017: total abdominal hysterectomy with bilateral salpingectomies: postoperative diagnoses: symptomatic uterine fibroids.Chronic pelvic pain.Menorrhagia.Dyspareunia.Chronic anemia.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: results: confirmed that fallopian tubes were fully occluded.Ultrasound scan - on an unknown date: results: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 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
|
|
