| Model Number ESS305 |
| Device Problems
Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Incontinence (1928); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Vomiting (2144); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Numbness (2415); Fungal Infection (2419); Sweating (2444); Confusion/ Disorientation (2553); Heavier Menses (2666); Foreign Body In Patient (2687)
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| Event Date 10/01/2013 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (food and drug administration, reference number: mw5035654) on 09-may-2014.The most recent information was received on 13-mar-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one coil missing/ malposition of essure coil (first essure device placed in left fallopian tube not visualized during hsg)/ failure to occlude (close) fallopian tube(s)"), suicidal ideation ("suicide thoughts") and genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding") in an adult female patient who had essure (batch no.634001gb/ a78080) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included factor v leiden mutation, multigravida, parity 6 ((b)(6)1994; (b)(6) 1998; (b)(6) 2008; (b)(6) 2009; (b)(6) 2010; (b)(6) 2013), missed abortion and d and c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included (b)(6), menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), fatigue ("major fatigue"), hypoaesthesia ("numbness and tingling in arms and legs") and feeling abnormal ("brain fog").In (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("mood swings"), rash ("unusual rashes"), anxiety ("anxiety"), panic attack ("panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("depression"), acne ("acne/ face break outs") and hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain"), nausea ("sick to my stomach every day"), arthralgia ("joint and hip pain/ hips pain"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), cystitis ("constant bladder infection and prolapse"), fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), dysmenorrhoea ("dysmenorrhea"), abdominal pain ("abdomen pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries"), influenza ("flu every day") and hyperhidrosis ("sweating").On an unknown date, the patient experienced vomiting ("vomiting"), myalgia ("major muscle pain") and endometriosis ("endometriosis").The patient was treated with surgery (essure was removed).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, suicidal ideation, abdominal pain lower, genital haemorrhage, alopecia, paraesthesia, pain in extremity, headache, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, arthralgia, dyspareunia, menorrhagia, depression, cystitis, hypoaesthesia, feeling abnormal, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, back pain, adnexa uteri pain, influenza and hyperhidrosis outcome was unknown and the vomiting, myalgia and endometriosis outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, cystitis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).Hysterosalpingogram - on (b)(6) 2013: only one essure device in the pelvis.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Most recent follow-up information incorporated above includes: on 13-mar-2018: medical record was received reporter information, lot number updated.Concomitant disease was added from mr.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("expulsion / first essure device placed in left fallopian tube not visualized during hsg) / failure to occlude (close) fallopian tube(s)/expulsion of essure device"), genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding"), bladder prolapse ("bladder infections and prolapse/bladder prolapse grade 2") and suicidal ideation ("suicide thoughts") in an adult female patient who had essure (batch no.634001gb-inv,a78080,b02264) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included factor v leiden mutation, multigravida, parity 6 (04may1994; 15jun1998; 14apr2008; 28feb2009; 23dec2010; 25mar2013), missed abortion and d & c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included hepatitis, hiv disease, tuberculosis, menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), hypoaesthesia ("neurological conditions or problems numbness and tingling in arms and legs") and feeling abnormal ("neurological conditions or problems-type brain fog").In (b)(6) 2013, the patient experienced fatigue ("major fatigue/fatigue"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and dysmenorrhoea ("dysmenorrhea(cramping)").In (b)(6) 2013, the patient experienced arthralgia ("joint and hip pain/ hips pain/joint pain"), fungal infection ("infection((bladder/urinary tract /vaginal)yeast infection"), bladder disorder ("bladder or urinary problems or changes") and migraine ("migraines").In (b)(6) 2013, the patient experienced nausea ("sick to my stomach every day/nausea").In (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("psychologiacal or psychiatric problems mood swings"), rash ("unusual rashes/rashes or skin conditions-type rashes"), anxiety ("psychologiacal or psychiatric problems :condition:anxiety"), panic attack ("psychologiacal or psychiatric problems panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("psychological or psuychiatric problems-condition depression") and acne ("acne/ face break outs/rashes or skin conditions -type acne") and was found to have hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced bladder prolapse (seriousness criterion medically significant), suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping/cramps"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain, severe and persistent pain as well as joint pain"), myalgia ("major muscle pain"), endometriosis ("endometriosis"), cystitis ("constant bladder infection and prolapse"), urinary tract disorder ("bladder or urinary problems or changes"), abdominal pain ("abdomen pain/abdominal pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries/ovarian pain"), influenza ("flu every day"), hyperhidrosis ("sweating/break out"), the first episode of emotional disorder ("hormonal changes: breakout"), abdominal pain upper ("pain all throughout my body ( stomach pain)") and the second episode of emotional disorder ("hormonal changes describe: break outs") and experienced vomiting ("vomiting").The patient was treated with surgery (anterior posterior colporraphy repair.And hysterectomy and bilateral salpingectomy).Essure was removed on 20-feb-2014.At the time of the report, the device expulsion, genital haemorrhage, bladder prolapse, suicidal ideation, abdominal pain lower, alopecia, paraesthesia, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, myalgia, endometriosis, dyspareunia, menorrhagia, depression, cystitis, fungal infection, hypoaesthesia, feeling abnormal, vaginal discharge, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, adnexa uteri pain, influenza, hyperhidrosis, migraine and the last episode of emotional disorder outcome was unknown, the pain in extremity, headache, arthralgia, back pain and abdominal pain upper was resolving and the vomiting outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, bladder prolapse, cystitis, depression, device expulsion, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, migraine, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vomiting, the first episode of emotional disorder and the second episode of emotional disorder to be related to essure.The reporter commented: 27sep2013,25sep2013 (discrepancy noted in confirmation dates) diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.2 kg/sqm.Hysterosalpingogram - on 25-sep-2013: results: only one essure device in the pelvis/ unilateral occlusion (right tube occluded).¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Lot number: 634001gb is invalid.Lot number: a78080 manufacture date: 2012-12 expiration date: 2015-12 lot number: b02264 manufacture date:2013-02 expiration date: 201602.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-may-2019: quality safety evaluation of ptc.Incident 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.
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Manufacturer Narrative
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This case was initially received via regulatory authority (food and drug administration, reference number: (b)(4) on (b)(6)2014.The most recent information was received on 25-jan-2019.This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("expulsion / first essure device placed in left fallopian tube not visualized during hsg) / failure to occlude (close) fallopian tube(s)/expulsion of essure device"), suicidal ideation ("suicide thoughts"), genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding") and bladder prolapse ("bladder infections and prolapse/bladder prolapse grade 2") in an adult female patient who had essure (batch no.A78080/634001gb,b02264) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included factor v leiden mutation, multigravida, parity 6 (b)(6)1994; (b)(6)1998; (b)(6)2008; (b)(6)2009; (b)(6)2010; (b)(6)2013), missed abortion and d & c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included hepatitis, hiv disease, tuberculosis, menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6)2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), hypoaesthesia ("neurological conditions or problems numbness and tingling in arms and legs") and feeling abnormal ("neurological conditions or problems-type brain fog").In (b)(6)2013, the patient experienced fatigue ("major fatigue/fatigue"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)") and dysmenorrhoea ("dysmenorrhea(cramping)").In (b)(6)2013, the patient experienced arthralgia ("joint and hip pain/ hips pain/joint pain"), fungal infection ("infection((bladder/urinary tract /vaginal)yeast infection"), bladder disorder ("bladder or urinary problems or changes") and migraine ("migraines").In (b)(6)2013, the patient experienced nausea ("sick to my stomach every day/nausea").In (b)(6)2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("psychological or psychiatric problems mood swings"), rash ("unusual rashes/rashes or skin conditions-type rashes"), anxiety ("psychological or psychiatric problems :condition:anxiety"), panic attack ("psychological or psychiatric problems panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("psychological or psychiatric problems-condition depression") and acne ("acne/ face break outs/rashes or skin conditions -type acne") and was found to have hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping/cramps"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain, severe and persistent pain as well as joint pain"), myalgia ("major muscle pain"), endometriosis ("endometriosis"), cystitis ("constant bladder infection and prolapse"), urinary tract disorder ("bladder or urinary problems or changes"), abdominal pain ("abdomen pain/abdominal pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries/ovarian pain"), influenza ("flu every day"), hyperhidrosis ("sweating/break out"), bladder prolapse (seriousness criterion medically significant), the first episode of emotional disorder ("hormonal changes: breakout"), abdominal pain upper ("pain all throughout my body ( stomach pain)") and the second episode of emotional disorder ("hormonal changes describe: break outs") and experienced vomiting ("vomiting").The patient was treated with surgery (anterior posterior colporrhaphy repair.And hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6)2014.At the time of the report, the device expulsion, suicidal ideation, abdominal pain lower, genital haemorrhage, alopecia, paraesthesia, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, myalgia, endometriosis, dyspareunia, menorrhagia, depression, cystitis, fungal infection, hypoaesthesia, feeling abnormal, vaginal discharge, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, adnexa uteri pain, influenza, hyperhidrosis, bladder prolapse, migraine and the last episode of emotional disorder outcome was unknown, the pain in extremity, headache, arthralgia, back pain and abdominal pain upper was resolving and the vomiting outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, abdominal pain upper, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, bladder prolapse, cystitis, depression, device expulsion, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, migraine, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vomiting, the first episode of emotional disorder and the second episode of emotional disorder to be related to essure.The reporter commented: (b)(6)2013,(b)(6)2013 (discrepancy noted in confirmation dates).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.2 kg/sqm.Hysterosalpingogram - on (b)(6)2013: results: only one essure device in the pelvis/ unilateral occlusion (right tube occluded).¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Lot number: 634001gb is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jan-2019: pfs received.New events were added from pfs: migraines, pain all throughout my body ( stomach pain) and leg pain.Event outcome of hip pain, back pain, leg pain, headache was changed from unknown to recovering/resolving.Lot number added.Reporter information added.Incident: 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.
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Manufacturer Narrative
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Case was initially received via regulatory authority (food and drug administration, reference number: mw5035654) on 09-may-2014.The most recent information was received on 23-aug-2018.This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one coil missing/ malposition of essure coil (first essure device placed in left fallopian tube not visualized during hsg)/ failure to occlude (close) fallopian tube(s)"), suicidal ideation ("suicide thoughts") and genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding") in an adult female patient who had essure (batch no.A78080/634001gb) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included factor v leiden mutation, multigravida, parity 6 ((b)(6) 1994; (b)(6)1998; (b)(6) 2008; (b)(6) 2009; (b)(6) 2010; (b)(6) 2013), missed abortion and d & c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included hepatitis, hiv disease, tuberculosis, menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), fatigue ("major fatigue"), hypoaesthesia ("numbness and tingling in arms and legs") and feeling abnormal ("brain fog").In (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("mood swings"), rash ("unusual rashes"), anxiety ("anxiety"), panic attack ("panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("depression"), acne ("acne/ face break outs") and hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain"), nausea ("sick to my stomach every day"), arthralgia ("joint and hip pain/ hips pain"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), cystitis ("constant bladder infection and prolapse"), fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), dysmenorrhoea ("dysmenorrhea"), abdominal pain ("abdomen pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries"), influenza ("flu every day") and hyperhidrosis ("sweating").On an unknown date, the patient experienced vomiting ("vomiting"), myalgia ("major muscle pain") and endometriosis ("endometriosis").The patient was treated with surgery (essure was removed).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, suicidal ideation, abdominal pain lower, genital haemorrhage, alopecia, paraesthesia, pain in extremity, headache, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, arthralgia, dyspareunia, menorrhagia, depression, cystitis, hypoaesthesia, feeling abnormal, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, back pain, adnexa uteri pain, influenza and hyperhidrosis outcome was unknown and the vomiting, myalgia and endometriosis outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, cystitis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: only one essure device in the pelvis.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Lot number: 634001gb is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-aug-2018: quality safety evaluation of product technical compliant.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.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device expulsion ("expulsion / first essure device placed in left fallopian tube not visualized during hsg) / failure to occlude (close) fallopian tube(s)"), suicidal ideation ("suicide thoughts"), genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding") and bladder prolapse ("bladder infections and prolapse") in an adult female patient who had essure (batch no.A78080/634001gb) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included factor v leiden mutation, multigravida, parity 6 ((b)(6) 1994; (b)(6) 1998; (b)(6) 2008; (b)(6) 2009; (b)(6) 2010; (b)(6) 2013), missed abortion and d & c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included hepatitis, hiv disease, tuberculosis, menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), fatigue ("major fatigue"), hypoaesthesia ("numbness and tingling in arms and legs") and feeling abnormal ("brain fog").In (b)(6) 2013, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("mood swings"), rash ("unusual rashes"), anxiety ("anxiety"), panic attack ("panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("depression"), acne ("acne/ face break outs") and hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain, severe and persistent pain as well as joint pain"), nausea ("sick to my stomach every day"), arthralgia ("joint and hip pain/ hips pain"), myalgia ("major muscle pain"), endometriosis ("endometriosis"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), cystitis ("constant bladder infection and prolapse"), fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), dysmenorrhoea ("dysmenorrhea"), abdominal pain ("abdomen pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries"), influenza ("flu every day"), hyperhidrosis ("sweating/break out"), bladder prolapse (seriousness criterion medically significant) and emotional disorder ("hormonal changes: breakout").On an unknown date, the patient experienced vomiting ("vomiting").The patient was treated with hysterectomy and bilateral salpingectomy and essure was removed on 20-feb-2014.At the time of the report, the device expulsion, suicidal ideation, abdominal pain lower, genital haemorrhage, alopecia, paraesthesia, pain in extremity, headache, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, arthralgia, myalgia, endometriosis, dyspareunia, menorrhagia, depression, cystitis, hypoaesthesia, feeling abnormal, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, back pain, adnexa uteri pain, influenza, hyperhidrosis, bladder prolapse and emotional disorder outcome was unknown and the vomiting outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, bladder prolapse, cystitis, depression, device expulsion, dysmenorrhoea, dyspareunia, emotional disorder, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and vomiting to be related to essure.The reporter commented: (b)(6) 2013,(b)(6) 2013 (discrepancy noted in confirmation dates).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: only one essure device in the pelvis.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Lot number: 634001gb is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-oct-2018: pfs received event " breakout and device expulsion" 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.
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Manufacturer Narrative
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E was initially received via regulatory authority (food and drug administration, reference number: mw5035654) on 09-may-2014.The most recent information was received on 02-oct-2018.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one coil missing/ malposition of essure coil (first essure device placed in left fallopian tube not visualized during hsg)/ failure to occlude (close) fallopian tube(s)"), suicidal ideation ("suicide thoughts"), genital haemorrhage ("bleeding with clotting/ abnormal bleeding general)/ abnormal bleeding") and bladder prolapse ("bladder infections and prolapse") in an adult female patient who had essure (batch no.A78080/634001gb) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included factor v leiden mutation, multigravida, parity 6 ((b)(6) 1994; (b)(6) 1998; (b)(6) 2008; (b)(6) 2009; (b)(6) 2010; (b)(6) 2013), missed abortion and d & c.Previously administered products included for an unreported indication: heparin.Concurrent conditions included hepatitis, hiv disease, tuberculosis, menstrual disorder, numbness, pain (in the bilateral legs.), menometrorrhagia, cystocele (symptomatic.) and rectocele.Family history included acute myocardial infarction (father).On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced headache ("headaches/ headaches (frequent severe headaches)"), fatigue ("major fatigue"), hypoaesthesia ("numbness and tingling in arms and legs") and feeling abnormal ("brain fog").In (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), mood swings ("mood swings"), rash ("unusual rashes"), anxiety ("anxiety"), panic attack ("panic attacks"), gastrointestinal disorder ("bowel problems/ gastrointestinal or digestive system condition") with constipation, diarrhoea and irritable bowel syndrome, depression ("depression"), acne ("acne/ face break outs") and hormone level abnormal ("hormonal changes").On an unknown date, the patient experienced suicidal ideation (seriousness criterion medically significant), abdominal pain lower ("severe cramping/ cramping"), paraesthesia ("tingling and leg cramping pain/ numbness and tingling in arms and legs"), pain in extremity ("tingling and leg cramping pain / leg pain"), nausea ("sick to my stomach every day"), arthralgia ("joint and hip pain/ hips pain"), myalgia ("major muscle pain"), endometriosis ("endometriosis"), dyspareunia ("could not have sex due to pain/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal/menorrhagia)"), cystitis ("constant bladder infection and prolapse"), fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder or urinary problems or changes"), urinary tract disorder ("bladder or urinary problems or changes"), dysmenorrhoea ("dysmenorrhea"), abdominal pain ("abdomen pain"), back pain ("back pain"), adnexa uteri pain ("constant and severe stabbing pain in her ovaries"), influenza ("flu every day"), hyperhidrosis ("sweating/break out") and bladder prolapse (seriousness criterion medically significant).On an unknown date, the patient experienced vomiting ("vomiting").The patient was treated with surgery (hysterectomy and bilateral salpingectomy) and surgery (anterior posterior colporraphy rapair.).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, suicidal ideation, abdominal pain lower, genital haemorrhage, alopecia, paraesthesia, pain in extremity, headache, fatigue, mood swings, rash, anxiety, panic attack, nausea, gastrointestinal disorder, arthralgia, myalgia, endometriosis, dyspareunia, menorrhagia, depression, cystitis, hypoaesthesia, feeling abnormal, acne, hormone level abnormal, female sexual dysfunction, bladder disorder, urinary tract disorder, dysmenorrhoea, abdominal pain, back pain, adnexa uteri pain, influenza, hyperhidrosis and bladder prolapse outcome was unknown and the vomiting outcome was unknown.The reporter provided no causality assessment for pain in extremity and suicidal ideation with essure.The reporter considered abdominal pain, abdominal pain lower, acne, adnexa uteri pain, alopecia, anxiety, arthralgia, back pain, bladder disorder, bladder prolapse, cystitis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hyperhidrosis, hypoaesthesia, influenza, menorrhagia, mood swings, myalgia, nausea, panic attack, paraesthesia, rash, urinary tract disorder, vaginal discharge, vaginal haemorrhage and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: only one essure device in the pelvis.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: hair loss, pelvic pain, menorrhagia¿.Lot number: 634001gb is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2018: pfs received : new event added- bladder prolapse.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.
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