| Model Number ESS305 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Separation Failure (2547); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hemorrhage/Bleeding (1888); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Foreign Body In Patient (2687)
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| Event Date 07/01/2012 |
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Event Type
Injury
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Event Description
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Spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation"), device dislocation ("migration"), genital haemorrhage ("bleeds every day") and kidney infection ("kidney infection") in a (b)(6) female patient who had essure (batch no.005345) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's past medical history included c-section, parity and anemia.Concurrent conditions included nerve damage and obesity.Concomitant products included ibuprofen since 2012 and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced injury ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding menorrhagia"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish"), migraine ("migraines") and headache ("headaches,").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").On (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia") and back pain ("back pain").On an unknown date, the patient experienced anaemia ("anemic now") and fatigue ("always tired").The patient was treated with para-seltzer (excedrin), surgery (salpingo-oopherectomy; hysterectomy with salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the uterine perforation, device dislocation, menstrual disorder, alopecia, bacterial vaginosis, depression, anxiety, migraine, headache, dysmenorrhoea, injury and back pain outcome was unknown, the genital haemorrhage, vaginal haemorrhage and menorrhagia was resolving, the kidney infection, abdominal pain, nausea and vomiting had not resolved, the anaemia and fatigue had not resolved and the dyspareunia had resolved.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, headache, injury, kidney infection, menorrhagia, menstrual disorder, migraine, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: current weight (b)(6).Approximate weight at the time of essure placement (b)(6).Date(s) of removal: (b)(6) 2014 & (b)(6) 2017.Unilateral salpingo-oophorectomy; hysterectomy with unilateral salpingectomy diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(4).Hysterosalpingogram - on 18-oct-2012: total bilateral occlusion concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain, essure was not deployed properly and the coils protrude into the cavity.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 22-jun-2018: pfs received- new events added: abnormal bleeding (vaginal, menorrhagia), infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis, psychological or psychiatric problems condition: depression and mental anguish, migraines / headaches, dysmenorrhea (cramping), surgery (other) type of surgery: insertion injury, dyspareunia (painful sexual intercourse) were added.New reporter and lot number were added.Outcome of the event pelvic pain and abnormal bleeding was updated.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 uterine perforation ("perforation"), device dislocation ("migration"), genital haemorrhage ("bleeds every day") and kidney infection ("kidney infection") in a 27-year-old female patient who had essure (batch no.005345) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's past medical history included c-section, parity and anemia.Concurrent conditions included nerve damage and obesity.Concomitant products included ibuprofen since 2012 and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced procedural complication ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").On (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding menorrhagia"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish"), migraine ("migraines") and headache ("headaches,").On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").On (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), back pain ("back pain") and vaginal infection ("vaginal infection").On an unknown date, the patient experienced anaemia ("anemic now") and fatigue ("always tired").The patient was treated with para-seltzer (excedrin), surgery (salpingo-oopherectomy(bilateral), hysterectomy) and surgery (salpingo-oopherectomy(bilateral), hysterectomy).Essure was removed on (b)(6) 2014.At the time of the report, the uterine perforation, device dislocation, menstrual disorder, alopecia, bacterial vaginosis, depression, anxiety, migraine, headache, dysmenorrhoea, procedural complication, back pain and vaginal infection outcome was unknown, the genital haemorrhage, vaginal haemorrhage and menorrhagia was resolving, the kidney infection, abdominal pain, nausea and vomiting had not resolved, the anaemia and fatigue had not resolved and the dyspareunia had resolved.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, headache, kidney infection, menorrhagia, menstrual disorder, migraine, procedural complication, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6) 2014 & (b)(6) 2017 unilateral salpingo-oopherectomy; hysterectomy with unilateral salpingectomy diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain, essure was not deployed properly and the coils protrude into the cavity.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received- new event vaginal infection were added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation"), device dislocation ("migration"), endometritis ("chronic endometritis"), genital haemorrhage ("bleeds every day") and kidney infection ("kidney infection") in a 27-year-old female patient who had essure (batch no.005345) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's medical history included c-section, parity, anemia, weakness, fatigue and renal stone.Previously administered products included for an unreported indication: depo- provera.Concurrent conditions included nerve damage, obesity, ovarian cyst, right lower quadrant pain, pap smear abnormal, urinary tract infection and chest pain.Concomitant products included ibuprofen since 2012, medroxyprogesterone acetate (provera) and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced injury associated with device ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2012, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition:mental anguish").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014 the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced vaginal infection ("infection(bladder/urinary tract/vaginal)-type:vaginal").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), fatigue ("always tired") and back pain ("back pain") and experienced anaemia ("anemic now").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), fatigue ("always tired") and back pain ("back pain") and experienced anaemia ("anemic now").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), caffeine;paracetamol (excedrin), paracetamol (acetaminophen), surgery (diagnostic laparoscopy, lysis of adhesions and salpingo-oopherectomy(bilateral), hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device dislocation, endometritis, menstrual disorder, alopecia, bacterial vaginosis, depression, anxiety, migraine, headache, dysmenorrhoea, injury associated with device and vaginal infection outcome was unknown, the genital haemorrhage, abdominal pain, vaginal haemorrhage, menorrhagia and back pain was resolving, the kidney infection, fatigue, nausea and vomiting had not resolved, the anaemia had not resolved and the dyspareunia had resolved.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometritis, headache, injury associated with device, kidney infection, menorrhagia, menstrual disorder, migraine, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6) 2014: right salpingo-oophorectomy, unilateral salpingo-oopherectomy; hysterectomy with unilateral salpingectomy (b)(6) 2017:total laparoscopic hysterectomy with left salpingectomy.Findings: 1.Left fallopian tubes with 3 coils visualized.2.Right fallopian tube with 3 coils visualized.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Computerised tomogram - on (b)(6) 2015: multiple calcified stones within the right renal collecting system with the largest measuring 1.5 cm.Hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain, essure was not deployed properly and the coils protrude into the cavity and chronic endometritis.Concerning the injuries reported in this case, the following one was reported via medical records: endometritis quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 27-mar-2019: medical record received.Date of removal was updated.Reporter's information added.Added event from mr 'endometritis'.Medical history, concomitant condition were added.Fu9 &10 process together.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 uterine perforation ("perforation"), device dislocation ("migration"), endometritis ("chronic endometritis"), genital haemorrhage ("bleeds every day") and kidney infection ("kidney infection") in a 27-year-old female patient who had essure (batch no.005345-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's medical history included c-section, parity, anemia, weakness, fatigue and renal stone.Previously administered products included for an unreported indication: depo- provera.Concurrent conditions included nerve damage, obesity, ovarian cyst, right lower quadrant pain, pap smear abnormal, urinary tract infection and chest pain.Concomitant products included ibuprofen since 2012, medroxyprogesterone acetate (provera) and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced injury associated with device ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2012, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition:mental anguish").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced vaginal infection ("infection(bladder/urinary tract/vaginal)-type:vaginal").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired") and back pain ("back pain").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired") and back pain ("back pain").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), caffeine;paracetamol (excedrin), paracetamol (acetaminophen), surgery (diagnostic laparoscopy, right salpingoophorectomy, lysis of adhesions and salpingo-oopherectomy(bilateral), hysterectomy) and.Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device dislocation, endometritis, menstrual disorder, alopecia, bacterial vaginosis, depression, anxiety, migraine, headache, dysmenorrhoea, injury associated with device and vaginal infection outcome was unknown, the genital haemorrhage, abdominal pain, vaginal haemorrhage, menorrhagia and back pain was resolving, the kidney infection, anaemia, fatigue, nausea and vomiting had not resolved and the dyspareunia had resolved.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometritis, headache, injury associated with device, kidney infection, menorrhagia, menstrual disorder, migraine, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6) 2014:right salpingo-oophorectomy, unilateral salpingo-oopherectomy; hysterectomy with unilateral salpingectomy (b)(6) 2017:total laparoscopic hysterectomy with left salpingectomy.Findings: 1.Left fallopian tubes with 3 coils visualized.2.Right fallopian tube with 3 coils visualized.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Computerised tomogram - on (b)(6) 2015: multiple calcified stones within the right renal collecting system with the largest measuring 1.5 cm.Hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain, essure was not deployed properly and the coils protrude into the cavity and chronic endometritis.Concerning the injuries reported in this case, the following one was reported via medical records: endometritis quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 3-apr-2019: update of information (batch is invalid).Incident no valid 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 uterine perforation ('perforation'), device dislocation ('migration'), endometritis ('chronic endometritis'), genital haemorrhage ('bleeds every day') and kidney infection ('kidney infection') in a 27-year-old female patient who had essure (batch no.005345-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6)2012.The patient's medical history included c-section, parity, anemia, weakness, fatigue and renal stone.Previously administered products included for an unreported indication: depo- provera.Concurrent conditions included nerve damage, obesity, ovarian cyst, right lower quadrant pain, pap smear abnormal, urinary tract infection and chest pain.Concomitant products included ibuprofen since 2012, medroxyprogesterone acetate (provera) and paracetamol (tylenol) since 2012.On (b)(6)2012, the patient had essure inserted.On (b)(6)2012, the patient experienced injury associated with device ("surgery (other) type of surgery: insertion injury").In (b)(6)2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6)2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6)2012, the patient experienced depression ("psychological or psychiatric problems condition: depression/ psych injury") and anxiety ("psychological or psychiatric problems condition:mental anguish").In (b)(6)2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6)2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6)2014, the patient experienced vaginal infection ("infection(bladder/urinary tract/vaginal)-type:vaginal").In (b)(6)2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").In (b)(6)2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired"), back pain ("back pain"), rash ("rash/skin condition"), urinary tract infection ("uti") and hypersensitivity ("allergic reaction").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired"), back pain ("back pain"), rash ("rash/skin condition"), urinary tract infection ("uti") and hypersensitivity ("allergic reaction").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), caffeine;paracetamol (excedrin), paracetamol (acetaminophen), surgery (diagnostic laparoscopy, right salpingoophorectomy, lysis of adhesions and salpingo-oophorectomy(bilateral), hysterectomy) and.Essure was removed on (b)(6)2017.At the time of the report, the uterine perforation, device dislocation, endometritis, menstrual disorder, alopecia, depression, anxiety, migraine, headache, dysmenorrhoea, injury associated with device and rash outcome was unknown, the genital haemorrhage, vaginal haemorrhage, menorrhagia, bacterial vaginosis, dyspareunia, vaginal infection, urinary tract infection and hypersensitivity had resolved, the kidney infection, anaemia, fatigue, nausea and vomiting had not resolved and the abdominal pain and back pain was resolving.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometritis, headache, hypersensitivity, injury associated with device, kidney infection, menorrhagia, menstrual disorder, migraine, rash, urinary tract infection, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6)2014 :right salpingo-oophorectomy, unilateral salpingo-oopherectomy; hysterectomy with unilateral salpingectomy on (b)(6)2017:total laparoscopic hysterectomy with left salpingectomy.Findings: 1.Left fallopian tubes with 3 coils visualized.2.Right fallopian tube with 3 coils visualized.Patient received treatment pain.Bleeding.Urinary, bladder problem.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Computerised tomogram - on (b)(6)2015: multiple calcified stones within the right renal collecting system with the largest measuring 1.5 cm.Hysterosalpingogram - on (b)(6)2012: results: total bilateral occlusion.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: event outcome updated for events genital bleeding, vaginal bleeding, menorrhagia, vaginal infection, bacterial vaginosis, rcc added.New event added- allergic reaction.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 uterine perforation ('perforation'), device dislocation ('migration'), endometritis ('chronic endometritis'), genital haemorrhage ('bleeds every day') and kidney infection ('kidney infection') in a 27-year-old female patient who had essure (batch no.005345-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's medical history included c-section, parity, anemia, weakness, fatigue and renal stone.Previously administered products included for an unreported indication: depo- provera.Concurrent conditions included nerve damage, obesity, ovarian cyst, right lower quadrant pain, pap smear abnormal, urinary tract infection and chest pain.Concomitant products included ibuprofen since 2012, medroxyprogesterone acetate (provera) and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced injury associated with device ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6)2012, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition:mental anguish").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced vaginal infection ("infection(bladder/urinary tract/vaginal)-type:vaginal").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired"), back pain ("back pain"), rash ("rash/skin condition") and urinary tract infection ("uti").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired"), back pain ("back pain"), rash ("rash/skin condition") and urinary tract infection ("uti").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), caffeine;paracetamol (excedrin), paracetamol (acetaminophen), surgery (diagnostic laparoscopy, right salpingoophorectomy, lysis of adhesions and salpingo-oophorectomy(bilateral), hysterectomy) and.Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device dislocation, endometritis, menstrual disorder, alopecia, bacterial vaginosis, depression, anxiety, migraine, headache, dysmenorrhoea, injury associated with device, vaginal infection and rash outcome was unknown, the genital haemorrhage, abdominal pain, vaginal haemorrhage, menorrhagia and back pain was resolving, the kidney infection, anaemia, fatigue, nausea and vomiting had not resolved and the dyspareunia and urinary tract infection had resolved.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometritis, headache, injury associated with device, kidney infection, menorrhagia, menstrual disorder, migraine, rash, urinary tract infection, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6) 2014 :right salpingo-oophorectomy, unilateral salpingo-oophorectomy; hysterectomy with unilateral salpingectomy on (b)(6) 2017: total laparoscopic hysterectomy with left salpingectomy.Findings: 1.Left fallopian tubes with 3 coils visualized.2.Right fallopian tube with 3 coils visualized.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Computerised tomogram - on (b)(6) 2015: multiple calcified stones within the right renal collecting system with the largest measuring 1.5 cm.Hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: pelvic pain, essure was not deployed properly and the coils protrude into the cavity and chronic endometritis.Concerning the injuries reported in this case, the following one was reported via medical records: endometritis.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case included a device malfunction (device misfiring) event.No sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without batch number or sample.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 5-may-2020: new event "rash/skin condition" was added.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 uterine perforation ('perforation'), device dislocation ('migration'), endometritis ('chronic endometritis'), genital haemorrhage ('bleeds every day') and kidney infection ('kidney infection') in a 27-year-old female patient who had essure (batch no.005345-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "gun misfired and a coil came out of the tube and was hanging, spring clip had to be trimmed" in (b)(6) 2012.The patient's medical history included c-section, parity, anemia, weakness, fatigue and renal stone.Previously administered products included for an unreported indication: depo- provera.Concurrent conditions included nerve damage, obesity, ovarian cyst, right lower quadrant pain, pap smear abnormal, urinary tract infection and chest pain.Concomitant products included ibuprofen since 2012, medroxyprogesterone acetate (provera) and paracetamol (tylenol) since 2012.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced injury associated with device ("surgery (other) type of surgery: insertion injury").In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("severe right sided pain").In (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2012, the patient experienced depression ("psychological or psychiatric problems condition: depression/ psych injury") and anxiety ("psychological or psychiatric problems condition:mental anguish").In (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").On (b)(6) 2014, the patient experienced nausea ("nausea") and vomiting ("vomiting from pain").In (b)(6) 2014, the patient experienced vaginal infection ("infection(bladder/urinary tract/vaginal)-type:vaginal").In (b)(6) 2014, the patient experienced bacterial vaginosis ("infection (bladder/ urinary tract/vaginal) type: bacterial vaginosis").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, endometritis (seriousness criteria medically significant and intervention required), kidney infection (seriousness criterion medically significant), menstrual disorder ("menstruation issues"), alopecia ("alopecia"), anaemia ("anemic now"), fatigue ("always tired"), back pain ("back pain"), rash ("rash/skin condition"), urinary tract infection ("uti") and hypersensitivity ("allergic reaction").The patient was treated with acetylsalicylic acid;caffeine;paracetamol (excedrin migraine), caffeine;paracetamol (excedrin), paracetamol (acetaminophen), surgery (diagnostic laparoscopy, right salpingoophorectomy, lysis of adhesions and salpingo-oopherectomy(bilateral), hysterectomy) and.Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device dislocation, endometritis, menstrual disorder, alopecia, depression, anxiety, migraine, headache, dysmenorrhoea, injury associated with device and rash outcome was unknown, the genital haemorrhage, vaginal haemorrhage, menorrhagia, bacterial vaginosis, dyspareunia, vaginal infection, urinary tract infection and hypersensitivity had resolved, the kidney infection, anaemia, fatigue, nausea and vomiting had not resolved and the abdominal pain and back pain was resolving.The reporter provided no causality assessment for abdominal pain, anaemia, fatigue, genital haemorrhage, nausea and vomiting with essure.The reporter considered alopecia, anxiety, back pain, bacterial vaginosis, depression, device dislocation, dysmenorrhoea, dyspareunia, endometritis, headache, hypersensitivity, injury associated with device, kidney infection, menorrhagia, menstrual disorder, migraine, rash, urinary tract infection, uterine perforation, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: current weight 145 lbs.Approximate weight at the time of essure placement 189 lbs.Date(s) of removal: (b)(6) 2014 :right salpingo-oophorectomy, unilateral salpingo-oopherectomy; hysterectomy with unilateral salpingectomy on (b)(6) 2017:total laparoscopic hysterectomy with left salpingectomy.Findings: 1.Left fallopian tubes with 3 coils visualized.2.Right fallopian tube with 3 coils visualized.Patient received treatment pain.Bleeding.Urinary, bladder problem.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.5 kg/sqm.Computerised tomogram - on (b)(6) 2015: multiple calcified stones within the right renal collecting system with the largest measuring 1.5 cm.Hysterosalpingogram - on (b)(6) 2012: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jun-2020: quality safety evaluation of product technical complaint.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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Search Alerts/Recalls
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