| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Insert (1316); Device Or Device Fragments Location Unknown (2590); Biocompatibility (2886); Insufficient Information (3190); Migration (4003)
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| Patient Problems
Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Nausea (1970); Internal Organ Perforation (1987); Perforation (2001); Rash (2033); Respiratory Distress (2045); Tachycardia (2095); Tissue Damage (2104); Uterine Perforation (2121); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Malaise (2359); Disability (2371); Numbness (2415); Sweating (2444); Abdominal Cramps (2543); Weight Changes (2607); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 07/30/2013 |
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a lawyer in the united states, on behalf of a female plaintiff of unspecified age in united states on 03-aug-2015 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2013 for permanent sterilization.It was reported that in late 2012, plaintiff became pregnant of her fifth child and wanted a tubal ligation at the time of delivery.On (b)(6) 2013, she underwent an emergency caesarean section, because her umbilical cord had prolapsed around her fetus.Due to the emergent nature of the delivery, the tubal ligation was not performed.On (b)(6) 2013, during essure insertion, plaintiff immediately began reporting excruciating abdominal pain.She also experienced increased heart rate and profuse sweating.The procedure was abandoned after only placing one the two devices.It was stated that only three intrauterine coils were present after the unilateral placement.No nickel test was performed.One or more perforations occurred, including plaintiff's left fallopian tube and other internal organs.Between (b)(6) 2013 and (b)(6) 2013, she experienced unceasing agonizing pain due to the presence of the essure device.An x-ray was performed during the surgery to verify that the device was successfully removed.It showed that a piece of the coil was in fact left behind and was outside the fallopian tube and it was consistent with a perforation.Using the x-ray and a hysteroscopy, the physician concluded that pieces of the essure coil were left behind; however they could not locate them and decided to conclude the surgery.As a consequent decision of essure insertion, plaintiff suffered injury when the essure device failed, broke apart and caused perforations, causing her to suffer chest pains, elevated blood pressure, rapid breathing, excessive sweating, cramping, weight loss, itching, rashes, flu like symptoms, light headedness, dizziness, severe headaches, nausea, a nickel taste, pain in left side of the abdomen, a burning sensation in lower abdomen, tingling and numbness sensations in her hands and lips, diarrhea, stomach pain, fatigue and surgery including removal of her fallopian tubes and a hysterectomy.Ptc investigation result was received on 14-aug-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a product quality issue reported in the context of complicated device insertion and removal.The ae case refers to a usability issue.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse events considered related are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up received on 18-aug-2015: no new clinical information.Company causality comment: this non-medically confirmed, legal and spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and had one or more perforations, including plaintiff's left fallopian tube and other internal organs.She also stated that an x-ray was performed and it showed that a piece of the coil had in fact been left behind/ broke apart (device breakage).These events are serious due to medical importance and listed in the reference safety information for essure.Internal organs perforation may occur with essure, due to device migration or during insertion procedure.The perforation of internal bodily structures other than the uterus and fallopian tubes (e.G.Bowel, bladder, and major blood vessels) may occur during hysteroscopy, as well as during device placement; this risk is inherent with any hysteroscopic procedure.Due to the anatomical relationship between bowel and uterus, the bowel is the most commonly affected organ.In this case, it was not specify the exact organs perforated.As the perforations (fallopian tube and other internal organs) occurred at the time of essure insertion procedure and device breakage occurred during removal, a causal relationship between these events and suspect insert cannot be excluded.Since plaintiff underwent a hysterectomy and had her fallopian tubes removed, this case was regarded as incident.Additionally, non-serious events were reported.Additional information will be obtained through the normal litigation process.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.
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Manufacturer Narrative
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Data correction: the product code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('was outside the fallopian tube/ consistent with a perforation/ left fallopian tube perforation during insertion/ 1 felt the essure punctured through the wall outside my left fallopian tube/ it punctured through just out side of my tube'), device dislocation ('one or more perforations of other internal organs') and device breakage ('xray showed that a piece of the coil had in fact been left behind/ broke apart/ broken parts of essure device retained in left fallopian tube/ it punctured through just out side of my tube and broke into three pieces') in a 28-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, c-section on (b)(6) 2013, c-section and grand multiparity.X-ray result continued: was outside the fallopian tube and it was consistent with a perforation.The patient then states in may or june of 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.Previously administered products included for an unreported indication: lexapro and wellbutrin.Concurrent conditions included uti, anxiety, depression, weight gain, migraine, memory disturbance, micturition frequency increased, libido decreased, dysmenorrhea, dyspareunia, menorrhagia and cholecystectomy.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain, abdominal pain lower and abdominal discomfort, device dislocation (seriousness criteria medically significant and intervention required), complication of device insertion ("complication of device insertion"), procedural pain ("immediately began reporting excruciating abdominal pain"), hyperhidrosis ("profuse sweating/ sweating/ being sweaty/ sweating feeling hot a lot") and device insertion failed ("they abandoned the procedure after only placing one of the two devices/ essure device implanted failed/ procedure not completed on right tubal ostia") and was found to have heart rate increased ("increased heart rate").On (b)(6) 2013, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal/device removal failed").The patient was treated with surgery (vaginal hysterectomy and total unilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, complication of device insertion, procedural pain, heart rate increased, hyperhidrosis, device insertion failed, complication of device removal, chest pain, blood pressure increased, respiratory rate increased, weight decreased, pruritus, rash, influenza like illness, dizziness, headache, nausea, dysgeusia, paraesthesia oral, hypoaesthesia oral, paraesthesia, hypoaesthesia, diarrhoea, fatigue, abdominal pain upper, alopecia, pelvic pain, metamorphopsia, photophobia, phonophobia, hot flush, feeling hot, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis and peripheral swelling outcome was unknown and the back pain and nasal congestion had resolved.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, blood pressure increased, chest pain, chills, complication of device insertion, complication of device removal, cough, cystitis, depression, device breakage, device dislocation, diarrhoea, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, emotional disorder, fallopian tube perforation, fatigue, feeling abnormal, feeling hot, galactorrhoea, headache, heart rate increased, hot flush, hyperhidrosis, hypersensitivity, hypoacusis, hypoaesthesia, hypoaesthesia oral, influenza like illness, irritability, libido decreased, malaise, memory impairment, menorrhagia, metamorphopsia, migraine, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, neck pain, pain of skin, paraesthesia, paraesthesia oral, pelvic pain, peripheral swelling, personality change, phonophobia, photophobia, pollakiuria, procedural pain, productive cough, pruritus, rash, respiratory rate increased, sleep disorder, spinal pain, tremor, vulvovaginal pain, weight decreased, weight increased and device insertion failed to be related to essure.The reporter commented: discrepancy noted in insertion dates in pfs & mr- (b)(6) 2013, (b)(6)2013 the patient states insertion (b)(6) 2013 was done as an office procedure but essure was only able to be placed in the left fallopian tube and not in the right fallopian tube.At the time of cannulation of the left tubal ostia, patient began experiencing significant discomfort and complained of chest pain.She asked for the procedure to be aborted.The left fallopian tube had 3 intrauterine trailing coils.On (b)(6) 2013- essure coil was able to be grasped and pulled out of the tube.On may or june of 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.(b)(6) 2015- total vaginal hysterectomy with left salpingectomy with bilateral ovarian conservation (to remove broken parts of essure device, retained in the left fallopian tube as seen on ct scan).Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2014: 1.An essure device is seen on the left, projecting in the expected location of the left fallopian tube, medial end being lateral to the left uterine cornu.Ultrasound scan vagina - on (b)(6) 2013: echogenic essure coil noted in left upper cornua--unable to image col on right.X-ray - on (b)(6) 2013: results: a piece of the coil was in fact left behind and; on (b)(6) 2014: no abnormal bowel dilation.Bowel gas and stool seen throughout the colon and rectum.No suspicious calcifications.Cholecystectomy clips present.Left adnexrd essure device overlies left hemipelvis, unchanged in position since (b)(6) 2013.Non-obstructed bowel gas pattern.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical records : chest pain, pelvic pain, diarrhea, headaches, hot flushes, perforation of the device, procedural pain, abdominal pain, fatigue, paraesthesia, hypoaesthesia, alopecia, left lower abdominal pain.Concerning the injuries reported in this case, the following ones were reported via social media : feeling hot, tremor, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, nasal congestion, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis, peripheral swelling.Quality-safety evaluation of ptc: final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a product quality issue reported in the context of complicated device insertion and removal.The ae case refers to a usability issue.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse events considered related are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Most recent follow-up information incorporated above includes: on (b)(6) 2019: plaintiff fact sheet, medical records and social media contents received : events ¿abdominal pain(abdominal cramping)¿ updated to ¿abdominal pain lower¿.Event added- alopecia, pelvic pain, metamorphopsia, back pain, photophobia, phonophobia, hot flush, feeling hot, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, nasal congestion, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis, peripheral swelling.Outcome of event ¿nasal congestion, back pain¿ updated to ¿recovered/resolved.¿ verbatim ¿abdominal cramping when eating¿ clubbed with event ¿abdominal pain upper¿.Verbatim ¿congested & nausea¿ clubbed with event ¿nasal congestion and nausea¿.Verbatim ¿ripping feeling in stomach¿ clubbed with event ¿abdominal pain upper¿.Verbatim ¿changes in vision¿ updated with event ¿metamorphopsia¿.Verbatim ¿foggy head that i thought i was going to faint¿ clubbed with event ¿feeling abnormal¿.Medical history, concurrent conditions and historical drugs added.Lab details added.Removal date updated.Reporter information, patient details updated.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformance's 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 fallopian tube perforation ('was outside the fallopian tube/ consistent with a perforation/ left fallopian tube perforation during insertion/ 1 felt the essure punctured through the wall outside my left fallopian tube/ it punctured through just out side of my tube'), device dislocation ('one or more perforations of other internal organs') and device breakage ('xray showed that a piece of the coil had in fact been left behind/ broke apart/ broken parts of essure device retained in left fallopian tube/ it punctured through just out side of my tube and broke into three pieces') in a 28-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, c-section on (b)(6) 2013, c-section and grand multiparity.X-ray result continued: was outside the fallopian tube and it was consistent with a perforation.The patient then states in (b)(6) or (b)(6) of 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.Previously administered products included for an unreported indication: lexapro and wellbutrin.Concurrent conditions included uti, anxiety, depression, weight gain, migraine, memory disturbance, micturition frequency increased, libido decreased, dysmenorrhea, dyspareunia, menorrhagia and cholecystectomy.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain, abdominal pain lower and abdominal discomfort, device dislocation (seriousness criteria medically significant and intervention required), complication of device insertion ("complication of device insertion"), procedural pain ("immediately began reporting excruciating abdominal pain"), hyperhidrosis ("profuse sweating/ sweating/ being sweaty/ sweating feeling hot a lot") and device insertion failed ("they abandoned the procedure after only placing one of the two devices/ essure device implanted failed/ procedure not completed on right tubal ostia") and was found to have heart rate increased ("increased heart rate").On (b)(6) 2013, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal/device removal failed").Error in f_event_with_onset_srsns_nt:-6502-ora-06502: pl/sql: numeric or value error: character string buffer too small.Detail: line 1 ora-06512: at "bbs_owner.Pkg_custom_auto_narrative", line 11718.The patient was treated with surgery (vaginal hysterectomy and total unilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, complication of device insertion, procedural pain, heart rate increased, hyperhidrosis, device insertion failed, complication of device removal, chest pain, blood pressure increased, respiratory rate increased, weight decreased, pruritus, rash, influenza like illness, dizziness, headache, nausea, dysgeusia, paraesthesia oral, hypoaesthesia oral, paraesthesia, hypoaesthesia, diarrhoea, fatigue, abdominal pain upper, alopecia, pelvic pain, metamorphopsia, photophobia, phonophobia, hot flush, feeling hot, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis and peripheral swelling outcome was unknown and the back pain and nasal congestion had resolved.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, blood pressure increased, chest pain, chills, complication of device insertion, complication of device removal, cough, cystitis, depression, device breakage, device dislocation, diarrhoea, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, emotional disorder, fallopian tube perforation, fatigue, feeling abnormal, feeling hot, galactorrhoea, headache, heart rate increased, hot flush, hyperhidrosis, hypersensitivity, hypoacusis, hypoaesthesia, hypoaesthesia oral, influenza like illness, irritability, libido decreased, malaise, memory impairment, menorrhagia, metamorphopsia, migraine, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, neck pain, pain of skin, paraesthesia, paraesthesia oral, pelvic pain, peripheral swelling, personality change, phonophobia, photophobia, pollakiuria, procedural pain, productive cough, pruritus, rash, respiratory rate increased, sleep disorder, spinal pain, tremor, vulvovaginal pain, weight decreased, weight increased and device insertion failed to be related to essure.The reporter commented: discrepancy noted in insertion dates in pfs & mr- (b)(6) 2013, (b)(6) 2013.The patient states insertion (b)(6) 2013 was done as an office procedure but essure was only able to be placed in the left fallopian tube and not in the right fallopian tube.At the time of cannulation of the left tubal ostia, patient began experiencing significant discomfort and complained of chest pain.She asked for the procedure to be aborted.The left fallopian tube had 3 intrauterine trailing coils.On (b)(6) 2013-essure coil was able to be grasped and pulled out of the tube.On (b)(6) or (b)(6) of 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.(b)(6) 2015- total vaginal hysterectomy with left salpingectomy with bilateral ovarian conservation (to remove broken parts of essure device, retained in the left fallopian tube as seen on ct scan).Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2014: 1.An essure device is seen on the left, projecting in the expected location of the left fallopian tube, medial end being lateral to the left uterine cornu.Ultrasound scan vagina - on (b)(6) 2013: echogenic essure coil noted in left upper cornua--unable to image col on right.X-ray - on (b)(6) 2013: results: a piece of the coil was in fact left behind and; on (b)(6) 2014: no abnormal bowel dilation.Bowel gas and stool seen throughout the colon and rectum.No suspicious calcifications.Cholecystectomy clips present.Left adnexrd essure device overlies left hemipelvis, unchanged in position since (b)(6) 2013.Non-obstructed bowel gas pattern.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical records : chest pain, pelvic pain, diarrhea, headaches, hot flushes, perforation of the device, procedural pain, abdominal pain, fatigue, paraesthesia, hypoaesthesia, alopecia, left lower abdominal pain.Concerning the injuries reported in this case, the following ones were reported via social media : feeling hot, tremor, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, nasal congestion, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis, peripheral swelling.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-aug-2019: quality safety evaluation of ptc.Incident: no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('was outside the fallopian tube/ consistent with a perforation/ left fallopian tube perforation during insertion/ 1 felt the essure punctured through the wall outside my left fallopian tube/ it punctured through just out side of my tube'), device dislocation ('one or more perforations of other internal organs/echogenic essure coil noted in left upper cornu-unable to image coil on right') and device breakage ('xray showed that a piece of the coil had in fact been left behind/ broke apart/ broken parts of essure device retained in left fallopian tube/ it punctured through just out side of my tube and broke into three pieces') in a 28-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, c-section on (b)(6) 2013, c-section, parity 5, ectropion of cervix, dysplasia, lsil, gas evolution in intestine, cholelithiasis, gallstones, vomiting, constipation, cervical cancer, loop electrosurgical excision procedure, perforated eardrum, appetite lost, fainting, weakness, biliary colic, pap smear abnormal, asthma, gerd, heart murmur, threatened premature labor and vaginal delivery.X-ray result continued: was outside the fallopian tube and it was consistent with a perforation.The patient then states in (b)(6) 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.Previously administered products included for an unreported indication: lexapro and wellbutrin.Concurrent conditions included uti, anxiety, depression, memory disturbance, micturition frequency increased, libido decreased, dysmenorrhea, dyspareunia, menorrhagia, cholecystectomy, hypertension, sweaty, diabetes, acute gonococcal infection of lower genitourinary tract, chlamydial infection nos, human papilloma virus infection, gestational diabetes, pap smear abnormal and bipolar disorder.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain, abdominal pain lower and abdominal discomfort, device dislocation (seriousness criteria medically significant and intervention required), complication of device insertion ("complication of device insertion"), procedural pain ("immediately began reporting excruciating abdominal pain"), hyperhidrosis ("profuse sweating/ sweating/ being sweaty/ sweating feeling hot a lot") and device insertion failed ("they abandoned the procedure after only placing one of the two devices/ essure device implanted failed/ procedure not completed on right tubal ostia") and was found to have heart rate increased ("increased heart rate").On (b)(6) 2013, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal/device removal failed").Error in f_event_with_onset_srsns_nt:-6502-ora-06502: pl/sql: numeric or value error: character string buffer too small.Detail: line 1 ora-06512: at "bbs_owner.Pkg_custom_auto_narrative", line 11718.The patient was treated with surgery (vaginal hysterectomy and total unilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the fallopian tube perforation, device dislocation, device breakage, complication of device insertion, procedural pain, heart rate increased, hyperhidrosis, device insertion failed, complication of device removal, chest pain, blood pressure increased, respiratory rate increased, weight decreased, pruritus, rash, influenza like illness, dizziness, headache, nausea, dysgeusia, paraesthesia oral, hypoaesthesia oral, paraesthesia, hypoaesthesia, diarrhoea, fatigue, abdominal pain upper, alopecia, pelvic pain, visual impairment, photophobia, phonophobia, hot flush, feeling hot, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis and peripheral swelling outcome was unknown and the back pain and nasal congestion had resolved.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, blood pressure increased, chest pain, chills, complication of device insertion, complication of device removal, cough, cystitis, depression, device breakage, device dislocation, diarrhoea, disturbance in attention, dizziness, dysgeusia, dyspareunia, dyspepsia, dyspnoea, emotional disorder, fallopian tube perforation, fatigue, feeling abnormal, feeling hot, galactorrhoea, headache, heart rate increased, hot flush, hyperhidrosis, hypersensitivity, hypoacusis, hypoaesthesia, hypoaesthesia oral, influenza like illness, irritability, libido decreased, malaise, memory impairment, menorrhagia, migraine, musculoskeletal pain, nasal congestion, nasopharyngitis, nausea, neck pain, pain of skin, paraesthesia, paraesthesia oral, pelvic pain, peripheral swelling, personality change, phonophobia, photophobia, pollakiuria, procedural pain, productive cough, pruritus, rash, respiratory rate increased, sleep disorder, spinal pain, tremor, visual impairment, vulvovaginal pain, weight decreased, weight increased and device insertion failed to be related to essure.The reporter commented: discrepancy noted in insertion dates in pfs & mr- (b)(6) 2013, (b)(6) 2013 the patient states insertion (b)(6) 2013 was done as an office procedure but essure was only able to be placed in the left fallopian tube and not in the right fallopian tube.At the time of cannulation of the left tubal ostia, patient began experiencing significant discomfort and complained of chest pain.She asked for the procedure to be aborted.The left fallopian tube had 3 intrauterine trailing coils.On (b)(6) 2013-essure coil was able to be grasped and pulled out of the tube.On (b)(6) 2014, she underwent surgery for removal of "3 broken pieces of the essure." the patient states 2 of these 3 pieces were able to be removed and the patient underwent bilateral tubal ligation during the same surgery for permanent sterilization.(b)(6) 2015- total vaginal hysterectomy with left salpingectomy with bilateral ovarian conservation (to remove broken parts of essure device, retained in the left fallopian tube as seen on ct scan).Patient now wonders if ob/gyn shouldn't be more involved since the missing piece of essure is still there and showing up on the xray.Only fibers were present connecting the two inner coil ends.Suspect remaining metal piece remained in pelvis.The coil was visible under a thin film of peritoneum at the cornua of the uterus, appeared to be outside of the tube itself, consistent with a perforation.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2014: 1.An essure device is seen on the left, projecting in the expected location of the left fallopian tube, medial end being lateral to the left uterine cornu.Ultrasound scan vagina - on (b)(6) 2013: echogenic essure coil noted in left upper cornua--unable to image col on right.X-ray - on (b)(6) 2013: results: a piece of the coil was in fact left behind and; on (b)(6) 2013: there appeared to be remaining metal in the abdomen, in the left lower pelvis.; on (b)(6) 2014: no abnormal bowel dilation.Bowel gas and stool seen throughout the colon and rectum.No suspicious calcifications.Cholecystectomy clips present.Left adnexrd essure device overlies left hemipelvis, unchanged in position since (b)(6) 2013.Non-obstructed bowel gas pattern.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical records : chest pain, pelvic pain, diarrhea, headaches, hot flushes, perforation of the device, procedural pain, abdominal pain, fatigue, paraesthesia, hypoaesthesia, alopecia, left lower abdominal pain, upper abdominal pain, weight loss, nausea, back pain, depression, dyspnoea,abdominal distension, irritability, dyspepsia, headache/migraines, photophobia, phonophobia, visual impairment, disturbance in attention, pollakiuria, nasal congestion, dry cough, device breakage, device dislocation and fallopian tube perforation.Concerning the injuries reported in this case, the following ones were reported via social media : feeling hot, tremor, feeling abnormal, irritability, dyspnoea, nasopharyngitis, hypersensitivity, nasal congestion, cough, chills, weight increased, migraine, dyspepsia, hypoacusis, memory impairment, personality change, disturbance in attention, spinal pain, pain of skin, sleep disorder, pollakiuria, libido decreased, galactorrhoea, menorrhagia, depression, neck pain, vulvovaginal pain, musculoskeletal pain, dyspareunia, productive cough, abdominal distension, malaise, emotional disorder, cystitis, peripheral swelling.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: this is a retention case and all the information from deletion case 2017-224712 has been transferred to this case.Information included source documents and references.No new follow-up information was received from the reporter.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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