| Model Number ESS305 |
| Device Problems
Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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| Patient Problems
Unspecified Infection (1930); Pelvic Inflammatory Disease (2000); Perforation (2001); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165)
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| Event Date 06/01/2016 |
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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 perforation ("perforation by the device"), device dislocation ("migration of the device") and device breakage ("fracturing of the device") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "underwent failed removal of the device".On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and complication of device removal ("underwent failed removal of the device").The patient was treated with surgery, surgery and surgery.At the time of the report, the perforation, device dislocation, device breakage, infection and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage, device dislocation, infection and perforation to be related to essure.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 inflammatory disease ("postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis"), uterine perforation ("perforation by the device/perforation (uterus)/migration of device: uterus"), device expulsion ("migration of the device / migration of essure device location of device: uterus"), device breakage ("fracturing of the device"), genital haemorrhage ("abnormal bleeding (general)") and ovarian cyst ("ovarian cyst") in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain and gerd.Concomitant products included famotidine, ibuprofen, medroxyprogesterone acetate (depo provera), metoprolol and paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced genital haemorrhage (seriousness criterion medically significant), 1 year 4 months after insertion of essure.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish"), pelvic pain ("pain: pelvic area"), vaginal haemorrhage ("abnormal bleeding (vagina)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2016, the patient experienced abdominal pain ("abdominal area").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections"), the first episode of complication of device removal ("underwent failed removal of the device"), the second episode of complication of device removal ("underwent failed removal of the device") and abdominal pain lower ("abdominal pain lower").The patient was treated with azithromycin, ceftriaxone sodium (rocephin), doxycycline, hyoscyamine and surgery (salpingectomy (one side removal of fallopian tube), unilateral salpingectomy and unilateral salpingo-oopherectomy).Essure was removed.At the time of the report, the pelvic inflammatory disease, uterine perforation, device expulsion, device breakage, genital haemorrhage, infection, the last episode of complication of device removal, ovarian cyst, depression, anxiety, abdominal pain lower, vaginal haemorrhage, menorrhagia and abdominal pain outcome was unknown and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered abdominal pain, abdominal pain lower, anxiety, depression, device breakage, device expulsion, genital haemorrhage, infection, menorrhagia, ovarian cyst, pelvic pain, uterine perforation, vaginal haemorrhage, the first episode of complication of device removal and the second episode of complication of device removal to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: unilateral occlusion (right tube occluded).Smear cervix - on an unknown date: results: abnormal.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: pelvic inflammatory disease, ovarian cyst." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-apr-2019: pfs received.Events abnormal bleeding (general) and abdominal area 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 inflammatory disease ("postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis"), uterine perforation ("perforation by the device/perforation (uterus)/migration of device: uterus"), device expulsion ("migration of the device / migration of essure device location of device: uterus"), device breakage ("fracturing of the device") and ovarian cyst ("ovarian cyst") in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain and gerd.Concomitant products included famotidine, ibuprofen, medroxyprogesterone acetate (depo provera), metoprolol and paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish"), pelvic pain ("pain: pelvic area"), vaginal haemorrhage ("abnormal bleeding (vagina)") and menorrhagia ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections"), the first episode of complication of device removal ("underwent failed removal of the device"), the second episode of complication of device removal ("underwent failed removal of the device") and abdominal pain lower ("abdominal pain lower").The patient was treated with azithromycin, ceftriaxone sodium (rocephin), doxycycline, hyoscyamine and surgery (salpingectomy (one side removal of fallopian tube), unilateral salpingectomy and unilateral salpingo-oophorectomy).Essure was removed.At the time of the report, the pelvic inflammatory disease, uterine perforation, device expulsion, device breakage, infection, the last episode of complication of device removal, ovarian cyst, depression, anxiety, abdominal pain lower, vaginal haemorrhage and menorrhagia outcome was unknown and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered abdominal pain lower, anxiety, depression, device breakage, device expulsion, infection, menorrhagia, ovarian cyst, pelvic pain, uterine perforation, vaginal haemorrhage, the first episode of complication of device removal and the second episode of complication of device removal to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): smear cervix - on an unknown date: results: abnormal.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: pelvic inflammatory disease, ovarian cyst." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received- new event abnormal bleeding (vagina), abnormal bleeding (menorrhagia) were added.Medical history, concomitant and treatment drugs were 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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Ntaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis"), uterine perforation ("perforation by the device/perforation (uterus)/migration of device: uterus"), device dislocation ("migration of the device"), device breakage ("fracturing of the device") and ovarian cyst ("ovarian cyst") in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test" and device difficult to use "underwent failed removal of the device".The patient's past medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain.Concomitant products included paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish") and pelvic pain ("pain: pelvic area").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and complication of device removal ("underwent failed removal of the device").The patient was treated with ceftriaxone (rocephin), azithromycin, doxycycline, surgery, surgery (salpingectomy (one side removal of fallopian tube)), surgery (salpingectomy (one side removal of fallopian tube)), surgery (salpingectomy (one side removal of fallopian tube)) and surgery (unilateral salpingo-oopherectomy).At the time of the report, the pelvic inflammatory disease, uterine perforation, device dislocation, device breakage, infection, complication of device removal, ovarian cyst, depression and anxiety outcome was unknown and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered anxiety, complication of device removal, depression, device breakage, device dislocation, infection, ovarian cyst, pelvic pain and uterine perforation to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): smear cervix - on an unknown date: abnormal ¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: pelvic inflammatory disease, ovarian cyst." most recent follow-up information incorporated above includes: on 26-jun-2018: reporter information was added.This case concerns 35 year old patient.Her historical and concurrent condition was added.Lab data was added.Essure was ongoing at the time of the report.Essure lot number was added.Essure indication was amended.Treatment medications were added.Per medical record: event: pid (pelvic inflammatory disease) was added.Per plaintiff fact sheet following event: perforation by the device/perforation (uterus)/migration of device: uterus) (previously reported as perforation), ovarian cyst, depression, mental anguish, pain: pelvic area and she did not undergo essure confirmation test were added.She was recovering from event: pelvic pain.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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Spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis"), uterine perforation ("perforation by the device/perforation (uterus)/migration of device: uterus"), device expulsion ("migration of the device / migration of essure device location of device: uterus"), device breakage ("fracturing of the device") and ovarian cyst ("ovarian cyst") in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test" and device difficult to use "underwent failed removal of the device".The patient's past medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain.Concomitant products included paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish") and pelvic pain ("pain: pelvic area").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections"), complication of device removal ("underwent failed removal of the device") and abdominal pain lower ("abdominal pain lower").The patient was treated with ceftriaxone (rocephin), azithromycin, doxycycline, surgery (salpingectomy (one side removal of fallopian tube)), surgery (salpingectomy (one side removal of fallopian tube)), surgery (salpingectomy (one side removal of fallopian tube)) and surgery (unilateral salpingo-oophorectomy).Essure was removed.At the time of the report, the pelvic inflammatory disease, uterine perforation, device expulsion, device breakage, infection, complication of device removal, ovarian cyst, depression, anxiety and abdominal pain lower outcome was unknown and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered abdominal pain lower, anxiety, complication of device removal, depression, device breakage, device expulsion, infection, ovarian cyst, pelvic pain and uterine perforation to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): smear cervix - on an unknown date: abnormal.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: pelvic inflammatory disease, ovarian cyst." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-sep-2018: plaintiff fact sheet received.Event lower abdominal pain was added.Event device dislocation was updated to device expulsion.Product, patient & reporter information 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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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis"), uterine perforation ("perforation by the device/perforation (uterus)/migration of device: uterus"), device dislocation ("migration of the device"), device breakage ("fracturing of the device") and ovarian cyst ("ovarian cyst") in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test" and device difficult to use "underwent failed removal of the device".The patient's past medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain.Concomitant products included paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish") and pelvic pain ("pain: pelvic area").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections") and complication of device removal ("underwent failed removal of the device").The patient was treated with ceftriaxone (rocephin), azithromycin, doxycycline, surgery (salpingectomy (one side removal of fallopian tube)) and surgery (unilateral salpingo-oopherectomy).Essure was removed.At the time of the report, the pelvic inflammatory disease, uterine perforation, device dislocation, device breakage, infection, complication of device removal, ovarian cyst, depression and anxiety outcome was unknown and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered anxiety, complication of device removal, depression, device breakage, device dislocation, infection, ovarian cyst, pelvic pain and uterine perforation to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent essure removal and was currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): smear cervix - on an unknown date: abnormal ¿concerning the injuries reported in this case, the following ones were described in patient¿s medical record: pelvic inflammatory disease, ovarian cyst." quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-aug-2018: quality-safety evaluation of ptc.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 pelvic inflammatory disease ('postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis'), uterine perforation ('perforation by the device/perforation (uterus)/migration of device: uterus'), device expulsion ('migration of the device / migration of essure device location of device: uterus'), device breakage ('fracturing of the device') and ovarian cyst ('ovarian cyst') in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain and gerd.Concomitant products included famotidine, ibuprofen, medroxyprogesterone acetate (depo provera), metoprolol and paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), 1 year 4 months after insertion of essure.In (b)(6)2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish"), pelvic pain ("pain: pelvic area"), vaginal haemorrhage ("abnormal bleeding (vagina)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2016, the patient experienced abdominal pain ("abdominal area pain").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infections"), complication of device removal ("underwent failed removal of the device"), abdominal pain lower ("abdominal pain lower"), urinary tract infection ("uti") and post procedural complication ("post removal complication").The patient was treated with azithromycin, ceftriaxone sodium (rocephin), doxycycline, hyoscyamine and surgery (salpingectomy (one side removal of fallopian tube), unilateral salpingectomy and unilateral salpingo-oopherectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic inflammatory disease, device breakage, genital haemorrhage, infection, complication of device removal, ovarian cyst, depression, anxiety, abdominal pain lower, vaginal haemorrhage, menorrhagia, urinary tract infection and post procedural complication outcome was unknown, the uterine perforation, device expulsion and abdominal pain had resolved and the pelvic pain was resolving.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered abdominal pain, abdominal pain lower, anxiety, complication of device removal, depression, device breakage, device expulsion, genital haemorrhage, infection, menorrhagia, ovarian cyst, pelvic pain, post procedural complication, urinary tract infection, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Received treatment for pain, migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: unilateral occlusion (right tube occluded).Smear cervix - on an unknown date: results: abnormal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: plaintiff fact sheet received: new reporter added.Essure removal date , new event uti and post removal complication and rcc comment added a technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ('postoperative salpingitis plus postoperative tubo-ovarian complex/presumed pid post tubal sterilization/inflammatory disease present in the pelvis'), uterine perforation ('perforation by the device/perforation (uterus)/migration of device: uterus'), device expulsion ('migration of the device / migration of essure device location of device: uterus'), device breakage ('fracturing of the device') and ovarian cyst ('ovarian cyst') in a 35-year-old female patient who had essure (batch no.B40019) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included loop electrosurgical excision procedure.Concurrent conditions included abdominal pain and gerd.Concomitant products included famotidine, ibuprofen, medroxyprogesterone acetate (depo provera), metoprolol and paracetamol (acetaminophen).On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2016, the patient experienced genital haemorrhage ("abnormal bleeding (general)"), 1 year 4 months after insertion of essure.In (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), ovarian cyst (seriousness criterion medically significant), depression ("depression"), anxiety ("mental anguish"), pelvic pain ("pain: pelvic area"), vaginal haemorrhage ("abnormal bleeding (vagina)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2016, the patient experienced abdominal pain ("abdominal area pain").On an unknown date, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), infection ("infection"), complication of device removal ("underwent failed removal of the device"), abdominal pain lower ("abdominal pain lower"), urinary tract infection ("uti") and post procedural complication ("post removal complication").The patient was treated with azithromycin, ceftriaxone sodium (rocephin), doxycycline, hyoscyamine and surgery (salpingectomy (one side removal of fallopian tube), unilateral salpingectomy and unilateral salpingo-oopherectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic inflammatory disease, device breakage, genital haemorrhage, complication of device removal, ovarian cyst, depression, anxiety, abdominal pain lower, vaginal haemorrhage, menorrhagia and post procedural complication outcome was unknown and the uterine perforation, device expulsion, pelvic pain, abdominal pain and urinary tract infection had resolved.The reporter provided no causality assessment for pelvic inflammatory disease with essure.The reporter considered abdominal pain, abdominal pain lower, anxiety, complication of device removal, depression, device breakage, device expulsion, genital haemorrhage, infection, menorrhagia, ovarian cyst, pelvic pain, post procedural complication, urinary tract infection, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: per plaintiff fact sheet: had not underwent esure removal and was currently planning for essure removal.Received treatment for pain, migration.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: unilateral occlusion (right tube occluded).Smear cervix - on an unknown date: results: abnormal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received.Outcome of previously added events pelvic pain, uti were updated to recovered/resolved.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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