| Model Number ESS305 |
| Device Problems
Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)
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| Patient Problems
Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/05/2010 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("device migration") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain") and infection ("infection nos").The patient was treated with surgery (underwent a right salpingectomy due to complications).At the time of the report, the pelvic pain and infection outcome was unknown.The reporter considered device dislocation, infection and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingectomy - on an unknown date: essure device was successfully occluded.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("device migration") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain") and infection ("infection nos").The patient was treated with surgery (underwent a right salpingectomy due to complications).At the time of the report, the pelvic pain and infection outcome was unknown.The reporter considered device dislocation, infection and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingectomy - on an unknown date: essure device was successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-mar-2019: quality safety evaluation of product technical complaint.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain and chest pain.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx and cyst.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/pain") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/axiety").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection") and depression ("depression").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, device breakage, infection, depression, anxiety, nausea and dysmenorrhoea outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea and pelvic pain to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingectomy - on (b)(6) 2009: (as per pfs): result: total bilateral occlusion.(as per mr): conclusion: bilateral essure device in expected position with no evidence of tubal patency.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jul-2019: pfs & mr received.Events: depression, mental anguish/ anxiety, nausea, dysmenorrhea (cramping).Event added from removal details: the tip actually broke and this was taken out separately.Event device migration updated to migration of essure device location of device: myometrial cornua.Event outcome was updated for the event pelvic pain.Lab data was added.Concomitant drugs, conditions, historical drugs and reporter's information were added.Incident no lot number or device sample was received in this case.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain and chest pain.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx and paratubal cyst.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On 6-aug-2009, the patient experienced pelvic pain ("pelvic pain/pain") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/axiety").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection") and depression ("depression").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, device breakage, infection, depression, anxiety, nausea and dysmenorrhoea outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea and pelvic pain to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingectomy - on (b)(6) 2009: (as per pfs): result: total bilateral occlusion.(as per mr): conclusion: bilateral essure device in expected position with no evidence of tubal patency.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc(product technical complaint).No lot number or device sample was received in this case.We conducted 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua/migration') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain and chest pain.Previously administered products included for anxiety: lexapro on 28-dec-2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx and paratubal cyst.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/pain/chronic") and nausea ("nausea").In august 2009, the patient experienced anxiety ("mental anguish/axiety/psych injury").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), depression ("depression/psych injury"), abdominal pain ("abdominal pain"), bladder disorder ("bladder disorder nos") and urinary tract disorder ("urinary and diso").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, device breakage, infection, depression, anxiety, nausea and dysmenorrhoea outcome was unknown and the pelvic pain, abdominal pain, bladder disorder and urinary tract disorder had resolved.The reporter considered abdominal pain, anxiety, bladder disorder, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea, pelvic pain and urinary tract disorder to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Plaintiff received treatment for pain , ,migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingectomy - on (b)(6) 2009: (as per pfs): result: total bilateral occlusion.(as per mr): conclusion: bilateral essure device in expected position with no evidence of tubal patency.Bilateral occlusion.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Reporters information updated.Event : abdominal pain, bladder problem, urinary problem, were added.Event verbatim were updated: mental anguish/anxiety/psych injury, depression/psych injury, pelvic pain/pain/chronic, migration of essure device location of device: myometrial cornua/ migration.Event outcome were updated to recovered pelvic pain,abdominal pain, bladder problem, urinary problem.Incidnet: no lot number or device sample was received in this case.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua/migration') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain, chest pain and vaginal infection.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx and paratubal cyst.Concomitant products included escitalopram oxalate (lexapro) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/pain/chronic") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/axiety/psych injury").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), depression ("depression/psych injury"), abdominal pain ("abdominal pain"), bladder disorder ("bladder disorder nos"), urinary tract disorder ("urinary and diso"), post procedural complication ("post removal complications: yes") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, pelvic pain, abdominal pain, bladder disorder and urinary tract disorder had resolved and the device breakage, infection, depression, anxiety, nausea, dysmenorrhoea, post procedural complication and urinary tract infection outcome was unknown.The reporter considered abdominal pain, anxiety, bladder disorder, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea, pelvic pain, post procedural complication, urinary tract disorder and urinary tract infection to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Plaintiff received treatment for pain, migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: result: total bilateral occlusion.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: right lower quadrant pain, pain with intercourse concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, embedded device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: pif received.New events added: post removal complications, urinary tract infection.Outcome of previously added migration was updated to recovered/resolved.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua/migration') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain, chest pain and vaginal infection.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx and paratubal cyst.Concomitant products included escitalopram oxalate (lexapro) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On (b)(6)2009, the patient experienced pelvic pain ("pelvic pain/pain/chronic") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/anxiety/psych injury").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), depression ("depression/psych injury"), abdominal pain ("abdominal pain"), bladder disorder ("bladder disorder nos"), urinary tract disorder ("urinary and diso"), post procedural complication ("post removal complications: yes") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, pelvic pain, abdominal pain, bladder disorder and urinary tract disorder had resolved and the device breakage, infection, depression, anxiety, nausea, dysmenorrhoea, post procedural complication and urinary tract infection outcome was unknown.The reporter considered abdominal pain, anxiety, bladder disorder, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea, pelvic pain, post procedural complication, urinary tract disorder and urinary tract infection to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Plaintiff received treatment for pain , ,migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: result: total bilateral occlusion.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: right lower quadrant pain, pain with intercourse concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, embedded device quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: pif received.New events added: post removal complications , urinary tract infection.Outcome of previously added migration was updated to recovered/resolved.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua/migration') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain, chest pain and vaginal infection.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005.Concurrent conditions included right lower quadrant pain, hydrosalpinx, and paratubal cyst.Concomitant products included escitalopram oxalate (lexapro) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), 26 days after insertion of essure.On (b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/pain/chronic") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/anxiety/psych injury").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), depression ("depression/psych injury"), abdominal pain ("abdominal pain"), bladder disorder ("bladder disorder nos"), urinary tract disorder ("urinary and diso"), post procedural complication ("post removal complications: yes") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, pelvic pain, abdominal pain, bladder disorder, and urinary tract disorder had resolved and the device breakage, infection, depression, anxiety, nausea, dysmenorrhoea, post procedural complication, and urinary tract infection outcome was unknown.The reporter considered abdominal pain, anxiety, bladder disorder, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea, pelvic pain, post procedural complication, urinary tract disorder, and urinary tract infection to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Plaintiff received treatment for pain, migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: result: total bilateral occlusion.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: right lower quadrant pain, pain with intercourse concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, embedded device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of ptc.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('migration of essure device location of device: myometrial cornua/migration') and device breakage ('the tip actually broke and this was taken out separately') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included left lower quadrant pain, chest pain, vaginal infection and cyst.Previously administered products included for anxiety: lexapro on (b)(6) 2007; for an unreported indication: depo provera from 1993 to 2005, flagyl, dif1ucan and metrogel.Concurrent conditions included right lower quadrant pain, hydrosalpinx and paratubal cyst.Concomitant products included escitalopram oxalate (lexapro) and paracetamol (acetaminophen) since (b)(6) 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea(cramping)"), 26 days after insertion of essure.On(b)(6) 2009, the patient experienced pelvic pain ("pelvic pain/pain/chronic") and nausea ("nausea").In (b)(6) 2009, the patient experienced anxiety ("mental anguish/axiety/psych injury").On (b)(6) 2010, the patient experienced embedded device (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), depression ("depression/psych injury"), abdominal pain ("abdominal pain"), bladder disorder ("bladder disorder nos"), urinary tract disorder ("urinary and diso"), post procedural complication ("post removal complications: yes") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (unilateral salpingectomy - right on (b)(6) 2010 and removal of left coil).Essure was removed on (b)(6) 2010.At the time of the report, the embedded device, pelvic pain, abdominal pain, bladder disorder and urinary tract disorder had resolved and the device breakage, infection, depression, anxiety, nausea, dysmenorrhoea, post procedural complication and urinary tract infection outcome was unknown.The reporter considered abdominal pain, anxiety, bladder disorder, depression, device breakage, dysmenorrhoea, embedded device, infection, nausea, pelvic pain, post procedural complication, urinary tract disorder and urinary tract infection to be related to essure.The reporter commented: there were 4 coil showing on left and 4 coil also present on the right.Removal details- the patient had 2 umbilical punctures from the superior and inferior umbilical rings and went to the left side of the punctures from the left umbilical ring.This was continued up to the cornual portion of the tube.The tip of the essure was grasped with a small grasper and pulled.When we were pulling, the tip actually broke and this was taken out separately.There was no further essure noted after careful inspection.Plaintiff received treatment for pain , ,migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: result: total bilateral occlusion.Pathology test - on (b)(6) 2010: diagnosis: right fallopian tube: segment of fallopian tube with embedded coiled consistent with essure procedure.No evidence of salpingitis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: right lower quadrant pain, pain with intercourse concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dysmenorrhea, embedded device quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-apr-2021: mr received.Reporter information, patients details, other relevant history added.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.
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