| Model Number ESS305 |
| Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Asthma (1726); Cyst(s) (1800); Headache (1880); Unspecified Infection (1930); Miscarriage (1962); Pain (1994); Swelling (2091); Depression (2361); Weight Changes (2607); Foreign Body In Patient (2687)
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| Event Date 09/01/2010 |
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Event Type
Injury
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Event Description
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This case was initially received via regulatory authority (fda division director, reference number: mw5032720) on 13-jan-2014.The most recent information was received on 01-feb-2018.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("constant severe pelvic pain / severe and persistent pain / constant severe pain in pelvic region radiating into lower back and into legs"), device expulsion ("uterus showed that the essure devices were extruding through the tubal ostia into the uterine cavity") and abdominal distension ("severe bloating") in a (b)(6) 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 monitoring procedure not performed "did not undergo essure confirmation test".The patient's past medical history included gravida ii, parity 1 ((b)(6) 2002), premature delivery, c-section in 2002, amniotic cavity infection, miscarriage (@ 9 weeks.) on (b)(6) 2010, d & c in (b)(6) 2010, asthma, depression, migraine, clotting disorder and bronchitis.Concurrent conditions included overweight, irregular periods, allergic reaction to antibiotics and allergic reaction to antibiotics.Family history included dvt (mother), stroke (dad) and cerebrovascular disorder.Concomitant products included norethisterone (micronor) for irregular periods as well as anesthetics, general (general anesthesia) and oral contraceptive nos from (b)(6) 2010.In 2010, the patient experienced weight increased ("weight gain").In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required).On (b)(6)2010, the patient had essure inserted.On (b)(6) 2010, 6 days after insertion of essure, the patient experienced fatigue ("fatigue").On (b)(6) 2010, the patient experienced dysmenorrhoea ("dysmenorrhea").On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), abdominal distension (seriousness criteria hospitalization and medically significant), ovarian cyst ("cysts on ovary") and migraine ("migraines").The patient was treated with surgery (underwent total hysterectomy, bilateral salpingectomy and right oophorectomy.) and surgery (underwent abdominal hysterectomy, bilateral salpingectomy and right oophorectomy.).Essure was removed on (b)(6) 2010.At the time of the report, the pelvic pain, dysmenorrhoea, dyspareunia, fatigue and weight increased had resolved and the device expulsion, abdominal distension, ovarian cyst and migraine outcome was unknown.The reporter considered abdominal distension, device expulsion, dysmenorrhoea, dyspareunia, fatigue, migraine, ovarian cyst, pelvic pain and weight increased to be related to essure.The reporter commented: patient did not claim that essure worsened a previously existing injury/condition.Mr- left side - 6 coils, right side - 10 coils.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).On (b)(6) 2010 : us transvaginal : findings: the uterus is in the midline with a calculated volume of 91 ml, normal for age and parity.The endometrial thickness is 4 mm.It appears seeker tori.The myometrium is normal.There are artifacts from the essure coils which are known to be in place.These appear to be in the appropriate positions.The right ovarian volume is 7.5 ml per the left is 4.4 ml.There are follicles identified in both ovaries.There is no free fluid.Impression: essure coils as noted.Otherwise essentially normal pelvic ultrasound for age, parity and cycle status.On (b)(6) 2010 : surgical pathology report : pathologic diagnosis: corpus uteri, cervix and right uterine adnexa; hysterectomy and right salpingooophorectomy:1.Cervix: chronic active cervicitis 2.Endometrium: disordered proliferative pattern 3.Myometrium: adenomyosis, focal, superficial leiomyoma, sub serosal, 0.5 cm 4.Uterine serosa: fibrous thickening 5.Right fallopian tube: intraluminal metallic device (essure) including tip extending into uterine cavity 6.Right ovary: no histopathologic abnormality.Gross description: a metallic device is present in the specimen from the right fallopian tube into the uterine cavity.This device measures 2.8 cm in length.Sections from this area from the uterine cavity into the fallopian tube are submitted labeled k, l, m, o and p.Sections from the fallopian tube with the metallic device are submitted labeled q and r.The right fallopian tube measures 3.5 cm in length x 0.5 cm in diameter and the attached ovary measures 2.7 x 2,4 x 1.5 cm.On sectioning the ovary reveals multiple cystic cavities ranging from 0.1 up to 0.5 cm in diameter filled with clear fluid, also present is a corpus luteum measuring 0.3 cm in diameter.Current weight : (b)(6).Approximate weight at the time of essure placement: (b)(6).¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record : device expulsion ".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.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in (b)(6).¿ no testing methods performed.No results available since no evaluation performed.Unable to confirm complaint; device not returned.Medical assessment: the medical events reported are not indicative for a quality defect per se.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 1-feb-2018: pfs and medical records received.Events- "dysmenorrhea, dyspareunia, fatigue, weight gain, did not undergo essure confirmation test", historical condition, reporter added from pfs.Event "uterus showed that the essure devices were extruding through the tubal ostia into the uterine cavity", historical and concomitant condition, family history, lab data added from medical record.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 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 ("constant severe pelvic pain / severe and persistent pain / constant severe pain in pelvic region radiating into lower back and into legs"), device expulsion ("uterus showed that the essure devices were extruding through the tubal ostia into the uterine cavity") and abdominal distension ("severe bloating") in a 34-year-old female patient who had essure (batch no.709949) 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 "did not undergo essure confirmation test".The patient's medical history included gravida ii, parity 1 ((b)(6) 2002), premature baby less than 26 weeks, c-section in 2002, amniotic cavity infection, miscarriage (@ 9 weeks.) on (b)(6) 2010, d & c in (b)(6) 2010, asthma, depression, migraine, clotting disorder, bronchitis, abdominal pain, unilateral leg swelling, unilateral leg swelling, papanicolaou smear normal and adenomyosis.Current weight : 175 approximate weight at the time of essure placement: 150.Concurrent conditions included overweight, irregular periods, allergic reaction to antibiotics, allergic reaction to antibiotics, pelvic discomfort, gastroenteritis, ovarian cyst, lower abdominal pain, abdominal distension, chills, nausea and abdominal tenderness.Family history included dvt (mother), stroke (dad) and cerebrovascular disorder.Concomitant products included norethisterone (micronor) for irregular periods as well as anesthetics, general and oral contraceptive nos from (b)(6) 2010 to (b)(6) 2010.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, the patient experienced fatigue ("fatigue"), 6 days after insertion of essure.On (b)(6) 2010, the patient experienced dysmenorrhoea ("dysmenorrhea").On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia").On (b)(6) 2010, the patient was found to have weight increased ("weight gain").On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal distension (seriousness criteria hospitalization and medically significant), ovarian cyst ("cysts on ovary"), migraine ("migraines"), back pain ("constant severe pain in pelvic region radiating into lower back and into legs"), pain in extremity ("constant severe pain in pelvic region radiating into lower back and into legs") and abdominal pain lower ("cramping").The patient was treated with surgery (underwent abdominal hysterectomy, bilateral salpingectomy and right oophorectomy.And underwent total hysterectomy, bilateral salpingectomy and right oophorectomy/total abdominal hystere).Essure was removed on (b)(6) 2010.At the time of the report, the pelvic pain, dysmenorrhoea, dyspareunia, fatigue, weight increased, back pain, pain in extremity and abdominal pain lower had resolved and the device expulsion, abdominal distension, ovarian cyst and migraine outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, back pain, device expulsion, dysmenorrhoea, dyspareunia, fatigue, migraine, ovarian cyst, pain in extremity, pelvic pain and weight increased to be related to essure.The reporter commented: patient did not claim that essure worsened a previously existing injury/condition.Mr- left side - 6 coils, right side - 10 coils diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Computerised tomogram - on (b)(6) 2010: result: no acute intra-abdominal process; no renal/ureteral calculi.Computerised tomogram abdomen - on (b)(6) 2010: result: there is evidence of tubes seen in the fallopian tubes.There is evidence of fluid distended loops of small bowel consistent with gastroenteritis.Notes bowel obstruction.Pathology test - on (b)(6) 2010: result: pathologic diagnosis: corpus uteri, cervix and right uterine adnexa; hysterectomy and right salpingooophorectomy:1.Cervix: chronic active cervicitis.2.Endometrium: disordered proliferative pattern 3.Myometrium: adenomyosis, focal, superficial leiomyoma, sub serosal, 0.5 cm 4.Uterine serosa: fibrous thickening 5.Right fallopian tube: intraluminal metallic device (essure) including tip extending into uterine cavity 6.Right ovary: no histopathologic abnonnality gross description: a metallic device is present in the specimen from the right fallopian tube into the uterine cavity.This device measures 2.8 cm in length.Sections from this area from the uterine cavity into the fallopian tube are submitted labeled k, l, m, o and p.Sections from the fallopian tube with the metallic device are submitted labeled q and r.The right fallopian tube measures 3.5 cm in length x 0.5 cm in diameter and the attached ovary measures 2.7 x 2,4 x 1.5 cm.On sectioning the ovary reveals multiple cystic cavities ranging from 0.1 up to 0.5 cm in diameter filled with clear fluid, also present is a corpus luteum measuring 0.3 cm in diameter.Pregnancy test - on (b)(6) 2010: result: positive.Ultrasound scan - on (b)(6) 2010: result: uterus position: anteflexed uterus: l: 7.4 centimeters w: w measurement ap: 4.9 centimeters uterine lining:.52 centimeters uterine cavity: normal fallopian tube findings: abnormal; notable for bilateral essure seen cul de sac: small amount of fluid present estimated uterine weight was not obtained presence of fibroids: negative right ovary: abnormal; 3.6 centimeters by 1.9 centimeters; cystic; measurement of cyst: 1.6 centimeters left ovary: normal; 4.3 centimeters by 2.5 centimeters; normal consistency; on (b)(6) 2010: result: no evidence of ovarian torsion.; on (b)(6) 2010: result: findings: the uterus is in the midline with a calculated volume of 91 ml, normal for age and parity.The endometrial thickness is 4 mm.It appears seeker tori.The myometrium is normal.There are artifacts from the essure coils which are known to be in place.These appear to be in the appropriate positions.The right ovarian volume is 7.5 ml per the left is 4.4 ml.There are follicles identified in both ovaries.There is no free fluid.Impression: essure coils as noted.Otherwise essentially normal pelvic ultrasound for age, parity and cycle status.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record : device expulsion " quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-apr-2019: quality safety evaluation of ptc (product technical complaint).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 ("constant severe pelvic pain / severe and persistent pain / constant severe pain in pelvic region radiating into lower back and into legs"), device expulsion ("uterus showed that the essure devices were extruding through the tubal ostia into the uterine cavity") and abdominal distension ("severe bloating") in a 34-year-old female patient who had essure (batch no.709949) 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 "did not undergo essure confirmation test".The patient's medical history included gravida ii, parity 1 (b)(6)2002), premature baby less than 26 weeks, c-section in 2002, amniotic cavity infection, miscarriage (@ 9 weeks.) on (b)(6)2010, d & c in (b)(6)2010, asthma, depression, migraine, clotting disorder, bronchitis, abdominal pain, unilateral leg swelling, unilateral leg swelling, pap smear and adenomyosis.Current weight : 175 approximate weight at the time of essure placement: 150.Concurrent conditions included overweight, irregular periods, allergic reaction to antibiotics, allergic reaction to antibiotics, pelvic discomfort, gastroenteritis, ovarian cyst, lower abdominal pain, abdominal distension, chills, nausea and abdominal tenderness.Family history included dvt (mother), stroke (dad) and cerebrovascular disorder.Concomitant products included norethisterone (micronor) for irregular periods as well as anesthetics, general and oral contraceptive nos from (b)(6)2010 to (b)(6)2010.On (b)(6)2010, the patient had essure inserted.On (b)(6)-2010, the patient experienced fatigue ("fatigue"), 6 days after insertion of essure.On (b)(6)2010, the patient experienced dysmenorrhoea ("dysmenorrhea").On (b)(6)2010, the patient experienced dyspareunia ("dyspareunia").On (b)(6)2010, the patient was found to have weight increased ("weight gain").On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), abdominal distension (seriousness criteria hospitalization and medically significant), ovarian cyst ("cysts on ovary"), migraine ("migraines"), back pain ("constant severe pain in pelvic region radiating into lower back and into legs"), pain in extremity ("constant severe pain in pelvic region radiating into lower back and into legs") and abdominal pain lower ("cramping").The patient was treated with surgery (underwent abdominal hysterectomy, bilateral salpingectomy and right oophorectomy.And underwent total hysterectomy, bilateral salpingectomy and right oophorectomy/total abdominal hystere).Essure was removed on (b)(6)2010.At the time of the report, the pelvic pain, dysmenorrhoea, dyspareunia, fatigue, weight increased, back pain, pain in extremity and abdominal pain lower had resolved and the device expulsion, abdominal distension, ovarian cyst and migraine outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, back pain, device expulsion, dysmenorrhoea, dyspareunia, fatigue, migraine, ovarian cyst, pain in extremity, pelvic pain and weight increased to be related to essure.The reporter commented: patient did not claim that essure worsened a previously existing injury/condition.Mr- left side - 6 coils, right side - 10 coils diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.Computerised tomogram - on (b)(6)2010: result: no acute intra-abdominal process; no renal/ureteral calculi.Computerised tomogram abdomen - on (b)(6)2010: result: there is evidence of tubes seen in the fallopian tubes.There is evidence of fluid distended loops of small bowel consistent with gastroenteritis.Notes bowel obstruction.Pathology test - on (b)(6)2010: result: pathologic diagnosis: corpus uteri, cervix and right uterine adnexa; hysterectomy and right salpingooophorectomy:1.Cervix: chronic active cervicitis.2.Endometrium: disordered proliferative pattern 3.Myometrium: adenomyosis, focal, superficial leiomyoma, sub serosal, 0.5 cm 4.Uterine serosa: fibrous thickening 5.Right fallopian tube: intraluminal metallic device (essure) including tip extending into uterine cavity 6.Right ovary: no histopathologic abnonnality gross description: a metallic device is present in the specimen from the right fallopian tube into the uterine cavity.This device measures 2.8 cm in length.Sections from this area from the uterine cavity into the fallopian tube are submitted labeled k, l, m, o and p.Sections from the fallopian tube with the metallic device are submitted labeled q and r.The right fallopian tube measures 3.5 cm in length x 0.5 cm in diameter and the attached ovary measures 2.7 x 2,4 x 1.5 cm.On sectioning the ovary reveals multiple cystic cavities ranging from 0.1 up to 0.5 cm in diameter filled with clear fluid, also present is a corpus luteum measuring 0.3 cm in diameter.Pregnancy test - on (b)(6)2010: result: positive.Ultrasound scan - on (b)(6)2010: result: uterus position: anteflexed uterus: l: 7.4 centimeters w: w measurement ap: 4.9 centimeters uterine lining:.52 centimeters uterine cavity: normal fallopian tube findings: abnormal; notable for bilateral essure seen cul de sac: small amount of fluid present estimated uterine weight was not obtained presence of fibroids: negative right ovary: abnormal; 3.6 centimeters by 1.9 centimeters; cystic; measurement of cyst: 1.6 centimeters left ovary: normal; 4.3 centimeters by 2.5 centimeters; normal consistency; on (b)(6)2010: result: no evidence of ovarian torsion.; on (b)(6)2010: result: findings: the uterus is in the midline with a calculated volume of 91 ml, normal for age and parity.The endometrial thickness is 4 mm.It appears seeker tori.The myometrium is normal.There are artifacts from the essure coils which are known to be in place.These appear to be in the appropriate positions.The right ovarian volume is 7.5 ml per the left is 4.4 ml.There are follicles identified in both ovaries.There is no free fluid.Impression: essure coils as noted.Otherwise essentially normal pelvic ultrasound for age, parity and cycle status.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record : device expulsion " 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.No capa investigation is required per criteria established in wi-03635, ¿processing essure cases in dev@com.¿ fda evaluation codes method: 3323 ¿ no testing methods performed results: 3221 ¿ no results available since no evaluation performed conclusions: 67 ¿ unable to confirm complaint; 92 ¿ device not returned medical assessment the medical events reported are not indicative for a quality defect per se.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.Most recent follow-up information incorporated above includes: on 2019: pfs received.Essure lot number added.Other hcp added.Race information added.Event added: cramping.Event severity added for: constant severe pain in pelvic region radiating into lower back and into legs and pain in extremity.Event outcome updated for: pain in extremity.Lab data added.Medical history 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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E was initially received via regulatory authority (fda division director, reference number: mw (b)(4)) on 13-jan-2014.The most recent information was received on 10-oct-2018.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.No capa investigation is required per criteria established in (b)(4), ¿processing essure cases in dev@com.¿ fda evaluation codes method: 3323 ¿ no testing methods performed.Results: 3221 ¿ no results available since no evaluation performed.Conclusions: 67 ¿ unable to confirm complaint; 92 ¿ device not returned.Medical assessment: the medical events reported are not indicative for a quality defect per se.No batch number was reported.Without this information neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.At time of this medical evaluation the technical investigation concluded ¿unconfirmed quality defect¿.In summary, based on the available information there is no reason to suspect quality defect.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("constant severe pelvic pain / severe and persistent pain / constant severe pain in pelvic region radiating into lower back and into legs"), device expulsion ("uterus showed that the essure devices were extruding through the tubal ostia into the uterine cavity") and abdominal distension ("severe bloating") in a 34-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 monitoring procedure not performed "did not undergo essure confirmation test".The patient's past medical history included gravida ii, parity 1 ((b)(6) 2002), premature baby less than 26 weeks, c-section in 2002, amniotic cavity infection, miscarriage (@ 9 weeks.) on (b)(6) 2010, d & c in (b)(6) 2010, asthma, depression, migraine, clotting disorder and bronchitis.Concurrent conditions included overweight, irregular periods, allergic reaction to antibiotics and allergic reaction to antibiotics.Family history included dvt (mother), stroke (dad) and cerebrovascular disorder.Concomitant products included norethisterone (micronor) for irregular periods as well as anesthetics, general (general anesthesia) and oral contraceptive nos from 27-sep-2010 to 17-dec-2010.In 2010, the patient experienced weight increased ("weight gain").In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2010, 6 days after insertion of essure, the patient experienced fatigue ("fatigue").On (b)(6) 2010, the patient experienced dysmenorrhoea ("dysmenorrhea").On (b)(6) 2010, the patient experienced dyspareunia ("dyspareunia").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), abdominal distension (seriousness criteria hospitalization and medically significant), ovarian cyst ("cysts on ovary"), migraine ("migraines"), back pain ("constant severe pain in pelvic region radiating into lower back and into legs") and pain in extremity ("constant severe pain in pelvic region radiating into lower back and into legs").The patient was treated with surgery (underwent total hysterectomy, bilateral salpingectomy and right oophorectomy).Essure was removed on (b)(6) 2010.At the time of the report, the pelvic pain, dysmenorrhoea, dyspareunia, fatigue, weight increased and back pain had resolved and the device expulsion, abdominal distension, ovarian cyst, migraine and pain in extremity outcome was unknown.The reporter considered abdominal distension, back pain, device expulsion, dysmenorrhoea, dyspareunia, fatigue, migraine, ovarian cyst, pain in extremity, pelvic pain and weight increased to be related to essure.The reporter commented: patient did not claim that essure worsened a previously existing injury/condition.Mr- left side - 6 coils, right side - 10 coils diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.8 kg/sqm.On (b)(6) 2010 : us transvaginal : findings: the uterus is in the midline with a calculated volume of 91 ml, normal for age and parity.The endometrial thickness is 4 mm.It appears seeker tori.The myometrium is normal.There are artifacts from the essure coils which are known to be in place.These appear to be in the appropriate positions.The right ovarian volume is 7.5 ml per the left is 4.4 ml.There are follicles identified in both ovaries.There is no free fluid.Impression: essure coils as noted.Otherwise essentially normal pelvic ultrasound for age, parity and cycle status on (b)(6) 2010 : surgical pathology report : pathologic diagnosis: corpus uteri, cervix and right uterine adnexa; hysterectomy and right salpingooophorectomy:1.Cervix: chronic active cervicitis 2.Endometrium: disordered proliferative pattern 3.Myometrium: adenomyosis, focal, superficial leiomyoma, sub serosal, 0.5 cm 4.Uterine serosa: fibrous thickening 5.Right fallopian tube: intraluminal metallic device (essure) including tip extending into uterine cavity 6.Right ovary: no histopathologic abnonnality gross description: a metallic device is present in the specimen from the right fallopian tube into the uterine cavity.This device measures 2.8 cm in length.Sections from this area from the uterine cavity into the fallopian tube are submitted labeled k, l, m, o and p.Sections from the fallopian tube with the metallic device are submitted labeled q and r.The right fallopian tube measures 3.5 cm in length x 0.5 cm in diameter and the attached ovary measures 2.7 x 2,4 x 1.5 cm.On sectioning the ovary reveals multiple cystic cavities ranging from 0.1 up to 0.5 cm in diameter filled with clear fluid, also present is a corpus luteum measuring 0.3 cm in diameter.Current weight : 175.Approximate weight at the time of essure placement: 150.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record : device expulsion ".Most recent follow-up information incorporated above includes: on 10-oct-2018: pfs received.Added event constant severe pain in pelvic region radiating into lower back and into legs.Updated outcome.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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