| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Migration or Expulsion of Device (1395); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Abdominal Distention (2601); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Fallopian Tube Perforation (4506); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/16/2013 |
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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 ("migration") and device breakage ("remaining portions of plaintiffs essure device was confirmed and removed.") in a female patient (gravida -1, para -1) who received essure for contraception.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.On (b)(6) 2013, the patient started essure.In (b)(6) 2013, the patient experienced vaginal haemorrhage ("bleeding heavily"), headache ("headaches"), back pain ("lower back pain"), abdominal pain lower ("pain in lower abdomen"), pain ("constant pain from waist down") and adnexa uteri pain ("stabbing pain in both sides where ovaries are").In (b)(6) 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and clinically significant/intervention required) and menorrhagia ("menorrhagia").The patient was treated with surgery (device removal) and surgery (hysterectomy performed on (b)(6)2013).Essure was withdrawn.At the time of the report, the device dislocation, device breakage, menorrhagia, vaginal haemorrhage and pain outcome was unknown and the headache, back pain, abdominal pain lower, adnexa uteri pain and abdominal distension outcome was unknown.The reporter considered device dislocation, device breakage and menorrhagia to be related to essure.The reporter provided no causality assessment for vaginal haemorrhage, headache, back pain, abdominal pain lower, pain, adnexa uteri pain and abdominal distension with essure.Most recent follow-up information incorporated above includes: on 2-mar-2017: legal claim received - new events were reported and details of essure removal were also provided.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced device migration.Approximately 5 months after insertion procedure, coils were removed.After removal, she continued to experience severe pelvic pain and, approximately 6 months later, she underwent a hysterectomy and remaining portions of essure were confirmed and also removed (seen a device breakage) during essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus and out of the body; or a device dislocation within the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown; however, given its nature, the device dislocation was considered related to essure.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the exact time point of device breakage is unknown and it was only detected after coils had been removed, during a hysterectomy procedure.However, given it nature, the device breakage was assessed as related.This case was regarded as incident since intervention was required.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 29-mar-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced device migration.Approximately 5 months after insertion procedure, coils were removed.After removal, she continued to experience severe pelvic pain and, approximately 6 months later, she underwent a hysterectomy and remaining portions of essure were confirmed and also removed (seen a device breakage) during essure micro-insert therapy, there is a risk that the device could move.This movement could be a device expulsion into the uterus and out of the body; or a device dislocation within the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown; however, given its nature, the device dislocation was considered related to essure.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the exact time point of device breakage is unknown and it was only detected after coils had been removed, during a hysterectomy procedure.However, given it nature, the device breakage was assessed as related.This case was regarded as incident since intervention was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube )/migration/migration of essure device") and device breakage ("remaining portions of plaintiffs essure device was confirmed and removed.") in a 33-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's past medical history included parity 3.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2012, 9 months 7 days after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.In (b)(6) 2013, the patient experienced vaginal haemorrhage ("bleeding heavily"), headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down") and adnexa uteri pain ("stabbing pain in both sides where ovaries are").In (b)(6) 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").The patient was treated with surgery (operative laparoscopy,lysis of adhesions, partial salpingectomy) and surgery (hysterctomy performed on (b)(6) 2013).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation had resolved and the device breakage, menorrhagia, vaginal haemorrhage, headache, back pain, pain, adnexa uteri pain and abdominal distension outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered device breakage, fallopian tube perforation and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes there are inconsistencies on essure insertion removal dates between summons ((b)(6) 2013/(b)(6) 2013) and pfs ((b)(6) 2011/(b)(6) 2012).Conservatively and considering the narrative for the events, the first dates were kept.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received : new reporter was added.Patient demographic details added.Product indication, start and stop date updated.Product lot number added.Event was clubbed- abdominal pain lower /left lower quadrant pain.Event updated from device dislocation to fallopian tube perforation and new event device monitoring procedure not performed was added.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only 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 fallopian tube perforation ("perforation (fallopian tube )/migration/migration of essure device/ migration of essure device: tubal ostia") and device breakage ("remaining portions of plaintiffs essure device was confirmed and removed.") in a 34-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's past medical history included parity 3 and multigravida.Concurrent conditions included pain in extremity and weight gain.Concomitant products included medroxyprogesterone (depo provera), nsaid's and paracetamol (acetaminophen).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down") and adnexa uteri pain ("stabbing pain in both sides where ovaries are").In (b)(6) 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On (b)(6) 2013, 3 months 23 days after insertion of essure, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("bleeding heavily/ abnormal bleeding(vaginal)").In (b)(6) 2013, the patient experienced depression ("depression") and anxiety ("mental anguish").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (operative laparoscopy,lysis of adhesions, partial salpingectomy,hysterectomy (full)) and surgery (hysterctomy performed on (b)(6) 2013).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation had resolved and the device breakage, menorrhagia, vaginal haemorrhage, headache, back pain, pain, adnexa uteri pain, abdominal distension, depression, anxiety and dysmenorrhoea outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, fallopian tube perforation and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2013: negative ultrasound scan vagina - in (b)(6) 2013: total bilateral occlusion.; on an unknown date: total bilateral occlusion.On (b)(6) 2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons ((b)(6) 2013/(b)(6) 2013) and pfs ((b)(6) 2011/(b)(6) 2012).Conservatively and considering the narrative for the events, the first dates were kept.Lot numbers and exp/mfr dates 825627 jan2014 / jan2011, 869761 jun2014 / jun2011.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2018: plaintiff fact sheet received : events added: depression, dysmenorrhea (cramping) and mental anguish.Lab data was added.Concomitant drug was 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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Ntaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube )/migration/migration of essure device") and device breakage ("remaining portions of plaintiffs essure device was confirmed and removed.") in a 33-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's past medical history included parity 3 and multigravida.Concurrent conditions included pain in extremity and weight gain.On (b)(6) 2013, the patient had essure inserted.In february 2013, the patient experienced vaginal haemorrhage ("bleeding heavily"), headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down") and adnexa uteri pain ("stabbing pain in both sides where ovaries are").In march 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On an unknown date, 4 months 20 days after insertion of essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, device breakage (seriousness criteria medically significant and intervention required) and menorrhagia ("menorrhagia").The patient was treated with surgery (operative laparoscopy,lysis of adhesions, partial salpingectomy) and surgery (hysterctomy performed on (b)(6) 2013).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation had resolved and the device breakage, menorrhagia, vaginal haemorrhage, headache, back pain, pain, adnexa uteri pain and abdominal distension outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered device breakage, fallopian tube perforation and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2013: negative.On 27-dec-2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons (31-jan-2013/27-dec-2013) and pfs (13-sep-2011/19-jun-2012).Conservatively and considering the narrative for the events, the first dates were kept.Lot numbers and exp/mfr dates 825627 jan2014 / jan2011.869761 jun2014 / jun2011.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-jul-2018: quality-safety evaluation of ptc update.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 fallopian tube perforation ("perforation (fallopian tube )/migration/migration of essure device/ migration of essure device: tubal ostia") and device breakage ("remaining portions of plaintiffs essure device was confirmed and removed.") in a 34-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's past medical history included parity 3 and multigravida.Concurrent conditions included pain in extremity and weight gain.Concomitant products included medroxyprogesterone (depo provera), nsaid's and paracetamol (acetaminophen).On (b)(6)2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down") and adnexa uteri pain ("stabbing pain in both sides where ovaries are").In (b)(6)2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On (b)(6)2013, 3 months 23 days after insertion of essure, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("bleeding heavily/ abnormal bleeding(vaginal)").In june 2013, the patient experienced depression ("depression") and anxiety ("mental anguish").On 16-jun-2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (operative laparoscopy,lysis of adhesions, partial salpingectomy,hysterectomy (full)).Essure was removed on 12-jun-2013.At the time of the report, the fallopian tube perforation had resolved and the device breakage, menorrhagia, vaginal haemorrhage, headache, back pain, pain, adnexa uteri pain, abdominal distension, depression, anxiety and dysmenorrhoea outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, fallopian tube perforation and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6)2013: negative ultrasound scan vagina - in (b)(6)2013: total bilateral occlusion.; on an unknown date: total bilateral occlusion.On (b)(6)2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons (31-jan-2013/27-dec-2013) and pfs (13-sep-2011/19-jun-2012).Conservatively and considering the narrative for the events, the first dates were kept.Batch number: 825627 man date: 2011/01 exp date: 2014/01 batch number: 869761 man date: 2011/06 exp date: 2014/06 lot numbers and exp/mfr dates 825627 jan2014 / jan2011 869761 jun2014 / jun2011 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)-2018: quality safety evaluation of product technical complaints.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 fallopian tube perforation ('perforation (fallopian tube )/migration/migration of essure device/ migration of essure device: tubal ostia') and device breakage ('remaining portions of plaintiffs essure device was confirmed and removed.') in a 34-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's medical history included parity 3 and multigravida.Concurrent conditions included asthma since june 2013, pain in extremity and weight gain.Concomitant products included alprazolam, medroxyprogesterone acetate (depo provera), nsaids, paracetamol (acetaminophen) and salbutamol sulfate (albuterol sulfate) since january 2013.On (b)(6) 2013, the patient had essure inserted.In february 2013, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("bleeding heavily/ abnormal bleeding(vaginal)"), 3 months 23 days after insertion of essure.In february 2013, the patient experienced headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down"), adnexa uteri pain ("stabbing pain in both sides where ovaries are") and dysmenorrhoea ("dysmenorrhea (cramping)").In march 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), depression ("depression"), anxiety ("mental anguish") and hypersensitivity ("allergic reaction").The patient was treated with surgery (hysterctomy performed on (b)(6) 2013 and operative laparoscopy,lysis of adhesions, partial salpingectomy,hysterectomy (full)).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, menorrhagia and vaginal haemorrhage had resolved and the device breakage, headache, back pain, pain, adnexa uteri pain, abdominal distension, depression, anxiety, dysmenorrhoea and hypersensitivity outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, fallopian tube perforation, hypersensitivity and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes.Patient received treatment for pain, bleeding, migration.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2013: results: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.; in april 2013: results: total bilateral occlusion.Diagnostic results: on (b)(6) 2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons (31-jan-2013/27-dec-2013) and pfs (13-sep-2011/19-jun-2012).Conservatively and considering the narrative for the events, the first dates were kept.Batch number: 825627 man date: 2011/01 exp date: 2014/01.Batch number: 869761 man date: 2011/06 exp date: 2014/06.Lot numbers and exp/mfr dates: 825627 jan2014 / jan2011.869761 jun2014 / jun2011.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: event allergic reaction added.Event outcome updated: menorrhagia, vaginal hemorrhagia.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation (fallopian tube )/migration/migration of essure device/ migration of essure device: tubal ostia') and device breakage ('remaining portions of plaintiffs essure device was confirmed and removed.') in a 34-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's medical history included parity 3 and multigravida.Concurrent conditions included asthma since (b)(6) 2013, pain in extremity and weight gain.Concomitant products included alprazolam, medroxyprogesterone acetate (depo provera), nsaids, paracetamol (acetaminophen) and salbutamol sulfate (albuterol sulfate) since (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("bleeding heavily/ abnormal bleeding(vaginal)"), 3 months 23 days after insertion of essure.In (b)(6) 2013, the patient experienced headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down"), adnexa uteri pain ("stabbing pain in both sides where ovaries are") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), depression ("depression"), anxiety ("mental anguish") and hypersensitivity ("allergic reaction").The patient was treated with surgery (hysterctomy performed on (b)(6) 2013 and operative laparoscopy,lysis of adhesions, partial salpingectomy,hysterectomy (full)).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, menorrhagia and vaginal haemorrhage had resolved and the device breakage, headache, back pain, pain, adnexa uteri pain, abdominal distension, depression, anxiety, dysmenorrhoea and hypersensitivity outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, fallopian tube perforation, hypersensitivity and menorrhagia to be related to essure.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes.Patient received treatment for pain, bleeding, migration.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2013: results: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.; in (b)(6) 2013: results: total bilateral occlusion.Diagnostic results: on (b)(6) 2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons ((b)(6) 2013) and pfs ((b)(6) 2011/(b)(6) 2012).Conservatively and considering the narrative for the events, the first dates were kept.Batch number: 825627, man date: 2011/01, exp date: 2014/01.Batch number: 869761, man date: 2011/06, exp date: 2014/06.Lot number: 825627, manufacturing date: 2011/01, expiration date: 2014/01.Lot number: 869761, manufacturing date: 2011/06, expiration date: 2014/06.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 21-apr-2021: quality safety evaluation of ptc(product technical complaint).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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation (fallopian tube )/migration/migration of essure device/ migration of essure device: tubal ostia') and device breakage ('remaining portions of plaintiffs essure device was confirmed and removed.') in a 34-year-old female patient who had essure (batch no.825627,869761) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no essure confirmation test performed following insertion of essure".The patient's medical history included parity 3 and multigravida.Concurrent conditions included asthma since (b)(6) 2013, pain in extremity and weight gain.Concomitant products included alprazolam, medroxyprogesterone acetate (depo provera), nsaids, paracetamol (acetaminophen) and salbutamol sulfate (albuterol sulfate) since (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced menorrhagia ("menorrhagia") and vaginal haemorrhage ("bleeding heavily/ abnormal bleeding(vaginal)"), 3 months 23 days after insertion of essure.In (b)(6) 2013, the patient experienced headache ("headaches"), back pain ("lower back pain"), pain ("constant pain from waist down"), adnexa uteri pain ("stabbing pain in both sides where ovaries are") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2013, the patient experienced abdominal distension ("massive bloating in lower abdomen").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), depression ("depression"), anxiety ("mental anguish") and hypersensitivity ("allergic reaction").The patient was treated with surgery (hysterctomy performed on (b)(6) 2013 and operative laparoscopy,lysis of adhesions, partial salpingectomy,hysterectomy (full)).Essure was removed on (b)(6) -2013.At the time of the report, the fallopian tube perforation, menorrhagia and vaginal haemorrhage had resolved and the device breakage, headache, back pain, pain, adnexa uteri pain, abdominal distension, depression, anxiety, dysmenorrhoea and hypersensitivity outcome was unknown.The reporter provided no causality assessment for abdominal distension, adnexa uteri pain, back pain, headache, pain and vaginal haemorrhage with essure.The reporter considered anxiety, depression, device breakage, dysmenorrhoea, fallopian tube perforation, hypersensitivity and menorrhagia to be related to essure.No further causality assessment were provided for the product.The reporter commented: if plaintiff had essure removed, did any of the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal? yes.Patient received treatment for pain, bleeding, migration.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2013: results: negative.Ultrasound scan vagina - on an unknown date: results: total bilateral occlusion.; in (b)(6) 2013: results: total bilateral occlusion.Diagnostic results: on (b)(6) 2013, on hysteroscopy, there was a slightly thickened endometrial lining and the introducer of the right.On laparoscopy, there was normal pelvic anatomy.There are inconsistencies on essure insertion removal dates between summons ((b)(6) 2013) and pfs ((b)(6) 2011/(b)(6) 2012).Conservatively and considering the narrative for the events, the first dates were kept.Batch number: 825627, man date: 2011/01, exp date: 2014/01.Batch number: 869761, man date: 2011/06, exp date: 2014/06.Lot numbers and exp/mfr dates 825627 jan2014 / jan2011.869761 jun2014 / jun2011.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-apr-2021: mr received.Reporter information was added.Due to imrdf/fda codes follow-up marked significant.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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