| Model Number ESS305 |
| Device Problems
Misfire (2532); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Flatus (1865); Hair Loss (1877); Hemorrhage/Bleeding (1888); Pain (1994); Depression (2361); Inadequate Pain Relief (2388); Numbness (2415); Abdominal Cramps (2543); Weight Changes (2607)
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| Event Date 04/01/2012 |
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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 pelvic pain ("physical pain") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety, tachycardia, parity 3, multigravida (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007) and heartbeats irregular.Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderal.Concurrent conditions included obesity.Concomitant products included ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating").In (b)(6) 2012, the patient experienced back pain ("severe and persistent back pain ").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth"), breast pain ("severe and persistent breast pain"), dyspepsia ("heartburn") and fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), weight increased ("weight gain"), depression ("depression") and investigation noncompliance ("she did not undergo essure confirmation test").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure was removed in (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain and alopecia had resolved, the vaginal haemorrhage, weight increased, depression and sleep apnoea syndrome outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased 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 event cannot be totally excluded.However, the reported medical event is 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.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Events abnormal bleeding (vaginal), bleeding after sex,dysmenorrhea (cramping, dyspareunia (painful sexual intercourse), fatigue, hair loss, severe and persistent backpain, severe and persistent breast pain,weight gain,bloating,numbness in hands,metallic taste in mouth, heartburn,investigation noncompliance are added.Lab data updated.Historical drug and condition added.Concomitant drug and condition added.Product , patient & reporter information updated.Incident.No lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('physical pain') in a 33-year-old female patient who had essure (batch no.919031) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced".The patient's medical history included anxiety, tachycardia, multigravida, parity 3 (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007), heartbeats irregular and tachycardia (pregnancy related).Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderal.Concurrent conditions included obesity, depression, sleep apnea and gerd.Concomitant products included clonazepam (klonopin), ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.On(b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating") and dyspareunia ("dyspareunia") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe and persistent back pain") and breast pain ("severe and persistent breast pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth") and dyspepsia ("heartburn").In (b)(6) 2012, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), depression ("depression"), investigation noncompliance ("she did not undergo essure confirmation test"), menorrhagia ("abnormal bleeding (menorrhagia)"), complication associated with device ("complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced"), hot flush ("hot flashes"), migraine ("migraines"), abdominal pain ("abdominal pain"), swelling ("swelling") and allergy to metals ("allergic to nickel").The patient was treated with surgery (total hysterectomy and bilateral proximal salpingectomylaparoscopic-assisted vaginal hysterectomy).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain, alopecia and dyspareunia had resolved, the vaginal haemorrhage, weight increased, depression, sleep apnoea syndrome, investigation noncompliance, menorrhagia, complication associated with device, migraine, abdominal pain, swelling and allergy to metals outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, back pain, breast pain, coital bleeding, complication associated with device, depression, dysgeusia, dysmenorrhoea, dyspareunia, dyspepsia, fatigue, hot flush, hypoaesthesia, menorrhagia, migraine, pelvic pain, sleep apnoea syndrome, swelling, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.1 kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased concerning the injuries reported in this case, the following one were reported from social media report : hot flashes, migraines, abdominal pain, swelling, allergic to nickel.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: social media received: new events were added: hot flashes, migraines, abdominal pain, swelling, allergic to nickel.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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain") in a 33-year-old female patient who had essure (batch no.919031) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12 laced".The patient's medical history included anxiety, tachycardia, multigravida, parity 3 (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007), heartbeats irregular and tachycardia (pregnancy related).Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderal.Concurrent conditions included obesity, depression, sleep apnea and gerd.Concomitant products included clonazepam (klonopin), ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating") and dyspareunia ("dyspareunia") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe and persistent back pain") and breast pain ("severe and persistent breast pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth") and dyspepsia ("heartburn").In (b)(6) 2012, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), depression ("depression"), investigation noncompliance ("she did not undergo essure confirmation test"), menorrhagia ("abnormal bleeding (menorrhagia)") and complication associated with device ("complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12 laced").The patient was treated with surgery (total hysterectomy and bilateral proximal salpingectomylaparoscopic-assisted vaginal hysterectomy).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain, alopecia and dyspareunia had resolved, the vaginal haemorrhage, weight increased, depression, sleep apnoea syndrome, investigation noncompliance, menorrhagia and complication associated with device outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, alopecia, back pain, breast pain, coital bleeding, complication associated with device, depression, dysgeusia, dysmenorrhoea, dyspareunia, dyspepsia, fatigue, hypoaesthesia, menorrhagia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.1 kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased.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 event cannot be totally excluded.However, the reported medical event is 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.Most recent follow-up information incorporated above includes: on 18-feb-2019: plaintiff fact sheet and medical records received, reporter added, aka added, patient demographic added, lot number received, essure insertion and removal date updated, event added- dyspareunia.Events onset date added and outcome of the event dyspareunia is 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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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain") in a 33-year-old female patient who had essure (batch no.919031) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced".The patient's medical history included anxiety, tachycardia, multigravida, parity 3 (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007), heartbeats irregular and tachycardia (pregnancy related).Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderal.Concurrent conditions included obesity, depression, sleep apnea and gerd.Concomitant products included clonazepam (klonopin), ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating") and dyspareunia ("dyspareunia") and was found to have weight increased ("weight gain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("severe and persistent back pain") and breast pain ("severe and persistent breast pain").In july 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth") and dyspepsia ("heartburn").In (b)(6) 2012, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), depression ("depression"), investigation noncompliance ("she did not undergo essure confirmation test"), menorrhagia ("abnormal bleeding (menorrhagia)") and complication associated with device ("complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced").The patient was treated with surgery (total hysterectomy and bilateral proximal salpingectomylaparoscopic-assisted vaginal hysterectomy).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain, alopecia and dyspareunia had resolved, the vaginal haemorrhage, weight increased, depression, sleep apnoea syndrome, investigation noncompliance, menorrhagia and complication associated with device outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, alopecia, back pain, breast pain, coital bleeding, complication associated with device, depression, dysgeusia, dysmenorrhoea, dyspareunia, dyspepsia, fatigue, hypoaesthesia, menorrhagia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.1 kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-mar-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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain") in a 33-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety, tachycardia, multigravida, parity 3 (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007), heartbeats irregular and tachycardia (pregnancy related).Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderall.Concurrent conditions included obesity, depression, sleep apnea and gerd.Concomitant products included ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating").In (b)(6) 2012, the patient experienced back pain ("severe and persistent back pain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth"), breast pain ("severe and persistent breast pain"), dyspepsia ("heartburn") and fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), weight increased ("weight gain"), depression ("depression"), investigation noncompliance ("she did not undergo essure confirmation test") and menorrhagia ("abnormal bleeding (menorrhagia)").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure was removed in (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain and alopecia had resolved, the vaginal haemorrhage, weight increased, depression, sleep apnoea syndrome, investigation noncompliance and menorrhagia outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, menorrhagia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.1 kg/sqm.Concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs: investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased.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 event cannot be totally excluded.However, the reported medical event is 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.Most recent follow-up information incorporated above includes: on 2-oct-2018: per plaintiff fact sheet event: abnormal bleeding (menorrhagia) was added.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("physical pain") in a 33-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use issue "complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced".The patient's past medical history included anxiety, tachycardia, multigravida, parity 3 (date of births: (b)(6) 1997; (b)(6) 2006; (b)(6) 2007), heartbeats irregular and tachycardia (pregnancy related).Previously administered products included for an unreported indication: trileptal, buspar, klonopin, mirena, prozac, protonix and adderal.Concurrent conditions included obesity, depression, sleep apnea and gerd.Concomitant products included clonazepam (klonopin), ibuprofen, metoprolol, omeprazole (prilosec) and phentermine.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal distension ("bloating").In (b)(6) 2012, the patient experienced back pain ("severe and persistent back pain").In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dysgeusia ("metallic taste in mouth / gastrointestinal or digestive system condition: metallic taste in mouth"), breast pain ("severe and persistent breast pain"), dyspepsia ("heartburn") and fatigue ("fatigue").In (b)(6) 2013, the patient experienced hypoaesthesia ("numbness in hands that comes and goes / neurological conditions or problems/ intermittent numbness in hands") and alopecia ("hair loss").In (b)(6) 2017, the patient experienced sleep apnoea syndrome ("sleep apnea").On an unknown date, the patient experienced coital bleeding ("bleeding after sex"), weight increased ("weight gain"), depression ("depresion"), investigation noncompliance ("she did not undergo essure confirmation test"), menorrhagia ("abnormal bleeding (menorrhagia)") and complication associated with device ("complications or problems that occurred at time essure placement/ one misfired so she used two lots but she did not think the misfire 12laced").The patient was treated with surgery (total hysterectomy and bilateral salpingectomy).Essure was removed in (b)(6) 2013.At the time of the report, the pelvic pain, abdominal distension, dysmenorrhoea, coital bleeding, dysgeusia, back pain, breast pain and alopecia had resolved, the vaginal haemorrhage, weight increased, depression, sleep apnoea syndrome, investigation noncompliance, menorrhagia and complication associated with device outcome was unknown and the hypoaesthesia, dyspepsia and fatigue was resolving.The reporter provided no causality assessment for investigation noncompliance with essure.The reporter considered abdominal distension, alopecia, back pain, breast pain, coital bleeding, complication associated with device, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, menorrhagia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: doctor said one misfired so she used two lots but she did not think the misfire placed an essure in.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.1 kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s pfs investigation noncompliance abdominal distension, alopecia, back pain, breast pain, coital bleeding, depression, dysgeusia, dysmenorrhoea, dyspepsia, fatigue, hypoaesthesia, pelvic pain, sleep apnoea syndrome, vaginal haemorrhage and weight increased.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 event cannot be totally excluded.However, the reported medical event is 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.Most recent follow-up information incorporated above includes: on 10-oct-2018: pfs received: added new events: complication associated with device and device use issue and added concomitant medications.Incident no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Search Alerts/Recalls
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