| Model Number ESS305 |
| Device Problems
Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
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| Event Date 03/01/2014 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in a female patient who received essure for female sterilization.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient started essure.On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and clinically significant/intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), and back pain ("back pain").The patient was treated with surgery (hysterectomy in (b)(6) 2015).Essure was withdrawn.After this, she experienced procedural pain ("painful post-operative recovery").At the time of the report, the pelvic infection, genital haemorrhage, dysmenorrhoea and back pain outcome was unknown and the procedural pain outcome was unknown.The reporter considered pelvic infection, genital haemorrhage, dysmenorrhoea, back pain and procedural pain to be related to essure.Company causality comment: this case report refers to a female patient who had essure inserted and experienced infections (seen as pelvic infection).This event is anticipated in the reference safety information for essure.Coils were removed approximately 2 years after insertion.Upper genital tract infections, also referred to as pelvic inflammatory diseases (pids), occur when microorganisms ascend from the lower genital tract, infecting the uterus, fallopian tubes and ovaries.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.This present case has limited information and onset date of the event infection was not reported.However, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.This case was regarded as incident since intervention was required (device was removed).Other nonserious events were reported.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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Quality safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 7-feb-2017: the ptc investigation result was provided.Company causality comment: this case report refers to a female patient who had essure inserted and experienced infections (seen as pelvic infection) and excessive bleeding / blood clots (seen as genital hemorrhage).These events are anticipated in the reference safety information for essure.Coils were removed approximately 2 years after insertion.Upper genital tract infections, also referred to as pelvic inflammatory diseases (pids), occur when microorganisms ascend from the lower genital tract, infecting the uterus, fallopian tubes and ovaries.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.After essure insertion, abnormal genital bleeding and menses pattern changes may occur.This present case has limited information and onset dates of the events were not reported.However, based on a positive temporal relationship and lack of alternative explanation, causality between these serious event and suspect insert cannot be excluded.This case was regarded as incident since intervention was required (device was removed).Other nonserious events were reported.A product technical analysis resulted in an unconfirmed but plausible product quality defect and a relationship with the reported medical events cannot be totally excluded.No active follow-up is allowed and further information is expected only through litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("there are coiled metallic wires embedded in each cornu"), pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in an adult female patient who had essure (batch no.A27191) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included cesarean section.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, pelvic infection (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and infection ("infection (other)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy) and surgery (hysterectomy in (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, genital haemorrhage, dysmenorrhoea, back pain, menorrhagia and infection outcome was unknown.The reporter provided no causality assessment for embedded device with essure.The reporter considered back pain, dysmenorrhoea, genital haemorrhage, infection, menorrhagia, pelvic infection, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Diagnostic results: trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Concerning the injuries reported in this case, the following one were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received- all relevant medical history, lab test were added.Insertion and removal date of essure was updated and events there are coiled metallic wires embedded in each cornu, abnormal bleeding (vaginal), menorrhagia, infection and pelvic pain 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 embedded device ("there are coiled metallic wires embedded in each cornu"), pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in an adult female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's past medical history included multiple cesarean sections.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, pelvic infection (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and abscess ("infection (other)/abscess").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, genital haemorrhage, dysmenorrhoea, back pain, menorrhagia and abscess outcome was unknown.The reporter provided no causality assessment for embedded device with essure.The reporter considered abscess, back pain, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic infection, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Diagnostic results: trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Most recent follow-up information incorporated above includes: on (b)(6) 2018: event verbatim was updated as infection (other)/abscess and pt was updated as abscess.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 embedded device ("there are coiled metallic wires embedded in each cornu"), pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in an adult female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's past medical history included multiple cesarean sections.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.On 21-dec-2012, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, pelvic infection (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and infection ("infection (other)").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on 9-oct-2015.At the time of the report, the embedded device, pelvic infection, genital haemorrhage, dysmenorrhoea, back pain, menorrhagia and infection outcome was unknown.The reporter provided no causality assessment for embedded device with essure.The reporter considered back pain, dysmenorrhoea, genital haemorrhage, infection, menorrhagia, pelvic infection, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Diagnostic results: trailing coils in uterus: 3.On 30-jul-2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on 09-oct-2015it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Concerning the injuries reported in this case, the following one were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Most recent follow-up information incorporated above includes: on 14-may-2018: pfs was received: the event essure confirmation test was not performed was added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("there are coiled metallic wires embedded in each cornu"), pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in an adult female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's past medical history included multiple cesarean sections.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.Concomitant products included paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain ("pain pelvic and abdominal area").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, pelvic infection (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery") and abscess ("infection (other)/abscess").The patient was treated with ciprofloxacin and surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2014)).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, dysmenorrhoea, back pain, menorrhagia, abscess, urinary tract infection, depression and anxiety outcome was unknown and the genital haemorrhage, dyspareunia and abdominal pain was resolving.The reporter provided no causality assessment for embedded device with essure.The reporter considered abdominal pain, abscess, anxiety, back pain, depression, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic infection, procedural pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-aug-2018: plaintiff fact sheet received, events added: infection (bladder/ urinary tract/vaginal) type: uti, psychological or psychiatric problems condition: depression and mental anguish, dyspareunia (painful sexual intercourse), abdominal pain, outcome of events updated, events onset date updated, treatment drug added, concomitant drug added, lab data added.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("there are coiled metallic wires embedded in each cornu"), pelvic infection ("infections") and genital haemorrhage ("excessive bleeding / blood clots") in an adult female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's past medical history included multiple cesarean sections.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, pelvic infection (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia") and abscess ("infection (other)/abscess").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, genital haemorrhage, dysmenorrhoea, back pain, menorrhagia and abscess outcome was unknown.The reporter provided no causality assessment for embedded device with essure.The reporter considered abscess, back pain, dysmenorrhoea, genital haemorrhage, menorrhagia, pelvic infection, procedural pain and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Diagnostic results: trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jul-2018: quality safety evaluation of ptc.Fda codes and device problem code, manufacturing and expiration dates, addition of ptc global number reference.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 embedded device ('there are coiled metallic wires embedded in each cornu') and pelvic infection ('infections / infection (other) -describe:') in a 37-year-old female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's medical history included multiple cesarean sections.Trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Previously administered products included for an unreported indication: balziva.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.Concomitant products included paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain ("pain pelvic and abdominal area").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage ("excessive bleeding / blood clots"), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery") and abscess ("infection (other)/abscess").The patient was treated with ciprofloxacin and surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2014)).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, dysmenorrhoea, back pain, abscess, depression and anxiety outcome was unknown, the genital haemorrhage and dyspareunia was resolving and the vaginal haemorrhage, menorrhagia, urinary tract infection and abdominal pain had resolved.The reporter provided no causality assessment for embedded device with essure.The reporter considered abdominal pain, abscess, anxiety, back pain, depression, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic infection, procedural pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Plaintiff received treatment for pain diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received.Reporter information added.Event outcome were updated.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('there are coiled metallic wires embedded in each cornu') and pelvic infection ('infections / infection (other) -describe:') in a 37-year-old female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's medical history included multiple cesarean sections.Trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Previously administered products included for an unreported indication: balziva.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.Concomitant products included paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain ("pain pelvic and abdominal area").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage ("excessive bleeding / blood clots"), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery") and abscess ("infection (other)/abscess").The patient was treated with ciprofloxacin and surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2014)).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, dysmenorrhoea, back pain, abscess, depression and anxiety outcome was unknown, the genital haemorrhage and dyspareunia was resolving and the vaginal haemorrhage, menorrhagia, urinary tract infection and abdominal pain had resolved.The reporter provided no causality assessment for embedded device with essure.The reporter considered abdominal pain, abscess, anxiety, back pain, depression, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic infection, procedural pain, urinary tract infection and vaginal haemorrhage to be related to essure.No further causality assessment were provided for the product.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Plaintiff received treatment for pain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: mr received.Reporter's information added.Fu received.No new significant change made in medical context of case.Case made significant due to imdrf hardcheck.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('there are coiled metallic wires embedded in each cornu') and pelvic infection ('infections / infection (other) -describe:') in a 37-year-old female patient who had essure (batch no.A27191) 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 "essure confirmation test was not performed".The patient's medical history included multiple cesarean sections.Trailing coils in uterus: 3.On (b)(6) 2015, pathology report- final diagnosis: endometrial biopsy-secretory endometrium negative for endometrial lesion or malignancy and on (b)(6) 2015 it showed final diagnosis: uterus , tubes and cervix-secretory endometrium, adenomyosis, unremarkable cervix, fallopian tubes, two, no significant pathologic changes.Previously administered products included for an unreported indication: balziva.Concurrent conditions included unspecified disorder of thyroid, palpitations, shortness of breath, allergic reaction to antibiotics, chest pain, drug hypersensitivity and pelvic adhesions.Concomitant products included paracetamol (acetaminophen) from (b)(6) 2012 to (b)(6) 2015.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: mental anguish"), dyspareunia ("dyspareunia (painful sexual intercourse)") and abdominal pain ("pain pelvic and abdominal area").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage ("excessive bleeding / blood clots"), dysmenorrhoea ("severe and abnormal menstrual pain"), back pain ("back pain"), procedural pain ("painful post-operative recovery") and abscess ("infection (other)/abscess").The patient was treated with ciprofloxacin and surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2014)).Essure was removed on (b)(6) 2015.At the time of the report, the embedded device, pelvic infection, dysmenorrhoea, back pain, abscess, depression and anxiety outcome was unknown, the genital haemorrhage and dyspareunia was resolving and the vaginal haemorrhage, heavy menstrual bleeding, urinary tract infection and abdominal pain had resolved.The reporter provided no causality assessment for embedded device with essure.The reporter considered abdominal pain, abscess, anxiety, back pain, depression, dysmenorrhoea, dyspareunia, genital haemorrhage, heavy menstrual bleeding, pelvic infection, procedural pain, urinary tract infection and vaginal haemorrhage to be related to essure.No further causality assessment were provided for the product.The reporter commented: 1st device loaded through operating channel of hysteroscope, and inserted into the r tubal ostia.Trailing coils in uterus; 3.2nd device loaded through operating channel of hysteroscope, and inserted into the l tubal ostia.Trailing coils in uterus: 3.Plaintiff received treatment for pain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were reported via medical record event embedded device and also confirming events menorrhagia, pelvic pain.Lot number: a27191, manufacture date: 2012-07, and expiration date: 2015-07.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 5-may-2021: quality safety evaluation of ptc.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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