| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)
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| Patient Problems
Fatigue (1849); Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Pain (1994); Tissue Damage (2104); Arthralgia (2355); Disability (2371); Sleep Dysfunction (2517); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2010 |
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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 consumer in united states on (b)(6) 2015 which refers to herself.She is a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2009 for contraception (lot number not provided).Consumer reported that in the next 2-3 years after essure insertion she had crippling arthritic pain all over, it traveled all around her body.She contacted a metal testing company and was told that some of the symptoms of titanium allergies were arthritic pains.She had to have her essure removed on (b)(6) 2015.Product technical complaint investigation and final assessment were received on (b)(4) 2015: this adverse event report is related to a product technical complaint and was initiated due to a request for confirmation of quality.(b)(4).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 to look for any manufacturing deficiencies.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.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse event is not indicative of a quality deficit per se and is considered unrelated by the company.No batch number was reported.Without this information no batch signal cluster review in the (b)(4) database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow up information received on (b)(6) 2015 from consumer: she stated that essure was inserted on (b)(6) 2009 for sterilization and removed on (b)(6) 2015.During consultation at time of the insertion procedure, the patient had negative pap hpv and was on birth control pills.She was not pregnant; she was gravida 3 and para 2, her last nsvd (interpreted as normal spontaneous vaginal delivery) was in (b)(6) 2008.The consumer denied allergy to shellfish, iodine, nickel or ivp (interpreted as intravenous pyelogram) dye; she had no contraindications to the procedure.Toradol, valium and motrin were used as premedication; paracervical block was applied during the procedure.Approximately 2 years after insertion she lost her sense of smell almost completely.Her physician could not find a known cause for this after running a ct scan, mri and visited her neurologist and ent specialist.Soon after the loss of her sense of smell she started having joint pains in both arms and neck.This arthritic like pains became so severe and traveled from joint to joint that she had extreme trouble caring her children and performing duties at work.She also had general fatigue and hard time sleeping; she felt like was being slowly poisoned.Consumer mentioned that her physician removed almost the entire essure device minus a small amount of stainless steel that he could not find.In her medical records it was mentioned that the portion of the tube containing the device was dissected at the junction of the mesosalpinx and the tube proceeding medially.The center core of the essure was removed and then the outer spring.The medial portion of the fallopian tube was ligated and buried in the mesosalpinx.The hysterectomy was closed with eight sutures.Her blood loss was negligible, the patient awoke and went to the recovery room in good condition.The operation time was one hour and 5 minutes.Within 24 hours after the removal her chronic arthritic like pain was much improved and remained much improved at time of the report.She reported that she only has residual effects like stiffness; her sense of smell has not returned so far.Company causality comment: this non-medically confirmed spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthritis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find (interpreted as device breakage).The reported event, interpreted as polyarthritis, is considered serious due to medical importance and unlisted according to essure's reference safety information.The event device breakage is non-serious and listed.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthritis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.This case is regarded as incident due to required intervention for essure removal.A product technical analysis was performed and concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Additionally, non-serious events were reported.Further information (ptc updated) is expected.
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Manufacturer Narrative
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Follow-up information received by the physician who removed essure on (b)(6) 2015 the patient's weight was (b)(6) and height was (b)(6).Essure was inserted on (b)(6) 2009.Essure was removed by mini-laparotomy due to patient request and because it was medically necessary on (b)(6) 2015.During surgery, essure devices were found intact and in proper place.After essure removal, patient's symptoms resolved, she had immediate improvement.Follow-up received on 18-jun-2015: no new clinical information.Follow-up information received on 23-jun-2015 according to the physician, the stainless steel end on the (essure) coil is normally seemed; sometimes it did not find.It is a tiny piece.It is an inert piece of steel.It comes loose from it, from end of the inserter.He did not know if that tiny piece was get.Because of this, patients were told that there may be a tiny piece of steel left, so that in the future if they have an x-ray they won't be surprised or upset.It is not the part of the essure with the nickel.He stated that he was a remover physician; not the one who inserted it.Company causality comment: this non-medically confirmed spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthtitis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find (interpreted as device breakage).The reported event, interpreted as polyarthtitis, is considered serious due to medical importance and unlisted according to essure's reference safety information.The event device breakage is non-serious and listed.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthtitis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.This case is regarded as incident due to required intervention for essure removal.A product technical analysis was performed and concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Additionally, non-serious events were reported.No further information is expected.
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Manufacturer Narrative
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Follow-up information received on 08-oct-2015 this case is potential legal case now.New reporters were added.Her ethnicity was reported as caucasian.Her medical history included 3 pregnancies, 2 parities, one abortion and hypothyroidism (she took levothyroxine).She denied use of alcohol, tobacco and drug.Her brother had a brain tumor, her father had diabetes, her mother and grandfather had colon cancer and her maternal grandfather had ovarian cancer.Essure was inserted on (b)(6) 2009 for birth control.Hsg (hysterosalpíngogram) was done and confirmed occlusion.On (b)(6) 2013, patient complained of right heel pain for two weeks.Worse in the morning, lessens as the day goes on.Mild heel ttp at achille's insertion; likely plantar fasciitis vs achille's tendonitis.Plan: rest ice stretching and arch supports.On (b)(6) 2013, it was reported that plantar fasciitis was getting better.She complained of burning pain right lower back and right elbow pain, likely muscle spasm in the back.On (b)(6) 2013, right elbow pain for a couple of months was reported; aggravated by reaching and grabbing objects.No swelling.Diagnosis was lateral epicondylitis of elbow.In (b)(6) 2014, shortness of breath and back pain/upper left were reported.On (b)(6) 2014, she held her son on her lap, shortly afterward she experienced pain in left scapular area, pain with deep breathing and she felt short of breath.Palpable tenderness at mid back near the left infrascapular area.Assessment was midback muscular strain, no lung problem.On (b)(6) 2014, she complained of ovarian pain and right side lower abdomen pain.She had menses every 2 weeks at times, painful periods that she attributed to the essure placement.She also had decreased libido, altered sense of smell, fatigue and body aches.It was offered oral contraceptive pill to help regulate menses and with pain but she did not want to go back on ocp.Company causality comment: this non-medically confirmed, potential legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthritis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find (interpreted as device breakage).The reported polyarthritis is considered serious due to its medical importance and unlisted according to essure's reference safety information.The event device breakage is non-serious and listed.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthtitis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.This case is regarded as incident due to required intervention for essure removal.Additionally, non-serious events were reported.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Follow up 29-oct-2015: this follow-up has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 (fda-2014-n-0736-2152, awareness date 29-oct-2015).Patient reported that she had essure inserted in 2009 and three years later she lost her sense of smell almost completely.Soon after that she started having fatigue and a feeling of being poisoned.She then started having migrating arthritis-like pain all over her body.She had a tubal ligation to remove the device and her doctor said part of it was missing.Her fatigue went away for the most part but the arthritis came back.Her labs were terrible, anemia, vitamin deficiencies, blood issues, liver issues and heavy metal poisoning.She went through detox which helped her symptoms temporarily but the arthritis pain has returned and her smell will never be the same.She will most likely have to get a hysterectomy.This non-medically confirmed, potential legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthritis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find (interpreted as device breakage).She also reported heavy metal poisoning.Polyarthritis and metal poisoning are considered serious due to medical importance and are unlisted in the reference safety information for essure.The event device breakage is non-serious and listed.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthtitis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.Essure insert consists of a nickel-titanium alloy.Although in vitro testing has shown that nickel ions may be released from this device, it is unlikely that the amount of nickel released would be sufficient to cause a metal poisoning.Therefore this event was assessed as unrelated to the device.This case was regarded as incident since a device removal was required.Additionally, non-serious events were reported.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Follow up information received on 12-jan-2016 from medical records: on (b)(6) 2012: office visit the patient complained of unusual chemical smell in nose x 1 week.Attributes this to a loose screw she found in a water heating teapot a few weeks ago.Findings suggest viral or allergic condition.No evidence that suggests poisoning or brain tumor.On (b)(6) 2012: office visit abnormal odor is present all the time but worse in her home.It is aggravated by the odor of bread, sometimes causing nausea.She has had some headaches.On (b)(6) 2012: office visit she describes "bad" smell as chemical smell or sweet smell.Symptoms are worse around carbohydrates and often occur when she cooks.She related the start of symptoms to use of chinese water pot, and has disposed of pot.She also reports start of irregular menses, loss of libido and some hair loss that she says may be menopausal.Assessment: parosmia.On (b)(6) 2012: toxicology consult she develops an almost putrid smell near these foods (bread, other carbohydrates) that does not extinguish.Laboratory studies within acceptable limits, including heavy metals.She had 6 week flonase and sinus rinse without significant improvement.Mri was suggestive of chronic sinusitis, which is the most likely cause.Plan: augmentin.On (b)(6) 2015: visit note in 2009, essure was placed; there were changes in mood, fatigue, and anosmia.A urine sample showed borderline mercury and cadmium levels.She did have 6 metal fillings from many years ago.At that time, she experienced progressive and migratory joint pains from elbows, wrist, shoulders, hips, toes which is keeping her from sleeping.Removal of essure laparotomy (b)(6) 2015.Company causality comment: this non-medically confirmed, potential legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthritis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find (interpreted as device breakage).She also reported heavy metal poisoning.Polyarthritis and metal poisoning are considered serious due to medical importance and are unlisted in the reference safety information for essure.The event device breakage is non-serious and listed according to technical analysis.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthtitis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.Essure insert consists of a nickel-titanium alloy.Although in vitro testing has shown that nickel ions may be released from this device, it is unlikely that the amount of nickel released would be sufficient to cause a metal poisoning.Therefore this event was assessed as unrelated to the device.This case was regarded as incident since a device removal was required.Additionally, non-serious events were reported.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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Upon internal review it was noted that the following information was incorrectly submitted to 2951250-2016-00279.Follow-up information was received on 06-sep-2016: the hysterosalpingogram that confirmed satisfactory placement of both essure coils and full occlusion of both tubes was done on (b)(6) 2009.Sometime after the procedure, plaintiff began experience one or more of the following symptoms, including, but not limited to:severe abnormal menstrual pain, abnormal menstrual cycle, excessive bleeding, severe pelvic pain, back pain, pain during intercourse, headaches, allergic reaction, mood swings, abdominal pain, migration of the device, unwanted pregnancy, and fatigue.She reported to her healthcare provider that she was experiencing severe, chronic and arthritis like pain in multiple parts of her body as well as loss of smell (already reported previously) and irregular and heavy periods and cramping.Company causality comment this non-medically confirmed, potential legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and in the next 2-3 years after essure insertion she had crippling arthritic pain all over / joint pains in both arms and neck (interpreted as polyarthritis).She had to have her essure removed.Physician removed almost the entire essure device minus a small amount of stainless steel that he could not find(interpreted as device breakage).She also reported heavy metal poisoning.According to additional information, this case became legal.Polyarthritis and metal poisoning are unlisted in the reference safety information for essure.The event device breakage is listed according to technical analysis.Arthritis is inflammation of one or more of your joints.Uric acid crystals, infections or underlying disease, such as psoriasis or lupus, can cause some types of arthritis.Although it is not expected that essure could contribute to polyarthritis development, given the positive temporal relationship and in the lack of an alternative explanation, company considers causality with the suspect insert cannot be totally excluded in this case.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure removal, a causal relationship cannot be excluded.Essure insert consists of a nickel-titanium alloy.Although in vitro testing has shown that nickel ions may be released from this device, it is unlikely that the amount of nickel released would be sufficient to cause a metal poisoning.Therefore this event was assessed as unrelated to the device.This case was regarded as incident since a device removal was required.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further information will be obtained 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 arthralgia ("crippling arthritic pain all over / joint pains in both arms and neck/ arthritis like pain in multiples parts of body."), device breakage ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find") and metal poisoning ("heavy metal poisoning") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2, gravida in 2008, abortion nos, hypothyroidism, familial risk factor, abstains from alcohol and nonsmoker.Previously administered products included for an unreported indication: toradol, levothyroxine, motrin and valium.Concurrent conditions included overweight.On (b)(6) 2009, the patient had essure inserted.In 2011, the patient experienced anosmia ("2 years after insertion of essure she lost her sense of smell almost completely").In (b)(6) 2013, the patient experienced pain in extremity ("right heel pain").In (b)(6) 2013, the patient experienced back pain ("burning pain right lower back / back pain upper left") and muscle spasms ("muscle spasm in back").In (b)(6) 2013, the patient experienced epicondylitis ("lateral epicondylitis of elbow") with arthralgia.In (b)(6) 2014, the patient experienced dyspnoea ("shortness of breath"), musculoskeletal pain ("pain in left scapular area / pain with deep breathing") and muscle strain ("midback muscular strain").In (b)(6) 2014, the patient experienced adnexa uteri pain ("ovarian pain"), abdominal pain lower ("right side lower abdomen pain"), polymenorrhoea ("menses every 2 weeks at times / irregular periods"), dysmenorrhoea ("painful periods"), libido decreased ("decreased libido"), the first episode of fatigue ("fatigue") and pain ("body aches").On an unknown date, the patient experienced arthralgia (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), metal poisoning (seriousness criterion medically significant) with feeling abnormal, complication of device removal ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), the second episode of fatigue ("general fatigue"), insomnia ("hard time sleeping"), musculoskeletal stiffness ("residual effects like stiffness"), parosmia ("altered sense of smell"), anaemia ("anemia"), hypovitaminosis ("vitamin deficiencies"), blood disorder ("blood issues"), liver disorder ("liver issues"), menorrhagia ("heavy periods"), abdominal pain ("cramping"), tooth loss ("tooth loss"), pelvic pain ("pain"), neck pain ("pains that shoot up my neck") and oral pain ("pain that shoot up my neck into my mouth").The patient was treated with surgery.Essure was removed on (b)(6) 2015.At the time of the report, the arthralgia and anosmia had not resolved, the device breakage, metal poisoning, complication of device removal, pain in extremity, back pain, muscle spasms, epicondylitis, dyspnoea, musculoskeletal pain, muscle strain, adnexa uteri pain, abdominal pain lower, polymenorrhoea, dysmenorrhoea, libido decreased, pain, parosmia, anaemia, hypovitaminosis, blood disorder, liver disorder, menorrhagia, abdominal pain, tooth loss, pelvic pain, neck pain and oral pain outcome was unknown and the last episode of fatigue, insomnia and musculoskeletal stiffness had resolved.The reporter considered abdominal pain, anaemia, anosmia, arthralgia, blood disorder, device breakage, dysmenorrhoea, hypovitaminosis, insomnia, liver disorder, menorrhagia, metal poisoning, musculoskeletal stiffness, neck pain, oral pain, pelvic pain, polymenorrhoea, tooth loss and the second episode of fatigue to be related to essure.The reporter provided no causality assessment for abdominal pain lower, adnexa uteri pain, back pain, complication of device removal, dyspnoea, epicondylitis, libido decreased, muscle spasms, muscle strain, musculoskeletal pain, pain, pain in extremity, parosmia and the first episode of fatigue with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26 kg/sqm.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 to look for any manufacturing deficiencies.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.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse event is not indicative of a quality deficit per se and is considered unrelated by the company.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.Neither batch number nor complaint sample was available for a technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 22-nov-2017: events added- tooth loss, pain, pains that shoot up my neck and pain that shoot up my neck into my mouth.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4) and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: fda-(b)(4)) on (b)(6)2015.The most recent information was received on (b)(6)2018.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), genital haemorrhage ("abnormal bleeding"), the first episode of arthralgia ("crippling arthritic pain all over / joint pains in both arms and neck/ arthritis like pain in multiples parts of body./knee pain/ankle/wrists pain"), autoimmune disorder ("autoimmune disorder"), metal poisoning ("heavy metal poisoning") and vulval haemorrhage ("vulval petechiae") in a 48-year-old female patient who had essure (batch no.710399) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 2, gravida in january 2008, abortion nos, hypothyroidism, familial risk factor, abstains from alcohol and nonsmoker.*toxic metals - lead 8.9 ug/g (normal range < 2 ug/g) ct sinuses cont.: minimal mucosal thickening.Previously administered products included for an unreported indication: toradol, levothyroxine, motrin and valium.Concurrent conditions included overweight.On (b)(6)2009, the patient had essure inserted.In 2010, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding9vaginal menorrhegea )") and menorrhagia ("heavy periods").In 2011, the patient experienced anosmia ("2 years after insertion of essure she lost her sense of smell almost completely").In june 2013, the patient experienced pain in extremity ("right heel pain/toes pain/finger pain").In july 2013, the patient experienced back pain ("burning pain right lower back / back pain upper left") and muscle spasms ("muscle spasm in back").In november 2013, the patient experienced epicondylitis ("lateral epicondylitis of elbow").In january 2014, the patient experienced dyspnoea ("shortness of breath"), musculoskeletal pain ("pain in left scapular area / pain with deep breathing/shoulder pain") and muscle strain ("midback muscular strain").In february 2014, the patient experienced adnexa uteri pain ("ovarian pain"), abdominal pain lower ("right side lower abdomen pain"), polymenorrhoea ("menses every 2 weeks at times / irregular periods"), dysmenorrhoea ("painful periods"), libido decreased ("decreased libido") and pain ("body aches").In 2014, the patient experienced the first episode of fatigue ("fatigue").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), the first episode of arthralgia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), metal poisoning (seriousness criterion medically significant) with feeling abnormal, vulval haemorrhage (seriousness criterion medically significant), complication of device removal ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), the second episode of fatigue ("general fatigue/fatigue"), insomnia ("hard time sleeping"), musculoskeletal stiffness ("residual effects like stiffness"), the second episode of arthralgia ("right elbow pain/ migrating arthritis-like pain all over her body/migrating joint pain/ inflammatory joint pain."), parosmia ("altered sense of smell / dysosmia"), anaemia ("anemia"), hypovitaminosis ("vitamin deficiencies"), blood disorder ("blood issues"), liver disorder ("liver issues"), abdominal pain ("cramping"), tooth loss ("tooth loss"), pelvic pain ("pain"), the first episode of neck pain ("pains that shoot up my neck"), oral pain ("pain that shoot up my neck into my mouth"), alopecia ("hair loss"), dysgeusia ("sensory disorder of taste"), pain in jaw ("all joints including jaws "), the second episode of neck pain ("neck pain"), dental caries ("my dentist has found deep pockets in my molars") and gingival recession ("ihave noticed more recession") and was found to have blood iron decreased ("iron low").The patient was treated with surgery (unilateral bilateral essure microsurgical removal on (b)(6) 2015).Essure was removed on (b)(6)2015.At the time of the report, the device breakage, autoimmune disorder, metal poisoning, vulval haemorrhage, vaginal haemorrhage, complication of device removal, pain in extremity, back pain, muscle spasms, epicondylitis, musculoskeletal pain, muscle strain, adnexa uteri pain, abdominal pain lower, polymenorrhoea, dysmenorrhoea, libido decreased, pain, anaemia, hypovitaminosis, blood disorder, liver disorder, menorrhagia, abdominal pain, tooth loss, pelvic pain, oral pain, alopecia, dysgeusia, pain in jaw, the last episode of neck pain, dental caries and gingival recession outcome was unknown, the genital haemorrhage, the last episode of fatigue, insomnia, musculoskeletal stiffness, dyspnoea, parosmia and blood iron decreased had resolved and the anosmia had not resolved.The reporter provided no causality assessment for abdominal pain lower, adnexa uteri pain, back pain, complication of device removal, dyspnoea, epicondylitis, libido decreased, muscle spasms, muscle strain, musculoskeletal pain, pain, pain in extremity and parosmia with essure.The reporter considered abdominal pain, alopecia, anaemia, anosmia, autoimmune disorder, blood disorder, blood iron decreased, dental caries, device breakage, dysgeusia, dysmenorrhoea, genital haemorrhage, gingival recession, hypovitaminosis, insomnia, liver disorder, menorrhagia, metal poisoning, musculoskeletal stiffness, oral pain, pain in jaw, pelvic pain, polymenorrhoea, tooth loss, vaginal haemorrhage, vulval haemorrhage, the first episode of arthralgia, the first episode of fatigue, the first episode of neck pain, the second episode of arthralgia, the second episode of fatigue and the second episode of neck pain to be related to essure.The reporter commented: on (b)(6)2016: surgical removal of coil(s) anothr dat were providede hysterectomy with bilateral salpingectomy cross referenced with case number : (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26 kg/sqm.Computerised tomogram - on (b)(6)2009: results: total bilateral occlusion; on (b)(6)2012: results: small left maxillary likely mucous retention cyst.Hysterosalpingogram - on (b)(6)2009: results: satisfactory placement/ both tubes full occulsion.Nuclear magnetic resonance imaging brain - on (b)(6)2012: results: minimal chronic sinus disease.Concerning the injuries reported in this case, the following one/ones were reported via social media: dental caries and gingival recession quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the consumer, regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2018: content from medical record received.Events gum recession, dental caries were added.Product, patient & reporter information updated.Incident we received a lot number.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 case was initially received via regulatory authority (fda, reference number: fda-(b)(4)) on (b)(6)2015.The most recent information was received on 30-apr-2018.This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of arthralgia ("crippling arthritic pain all over / joint pains in both arms and neck/ arthritis like pain in multiples parts of body./knee pain/ankle/wrists pain"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune disorder"), device breakage ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), metal poisoning ("heavy metal poisoning") and vulval haemorrhage ("vulval petechiae") in a 48-year-old female patient who had essure (batch no.710399) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2, gravida in january 2008, abortion nos, hypothyroidism, familial risk factor, abstains from alcohol and nonsmoker.Previously administered products included for an unreported indication: toradol, levothyroxine, motrin and valium.Concurrent conditions included overweight.On (b)(6)2009, the patient had essure inserted.In 2010, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding9vaginal menorrhegea )") and menorrhagia ("heavy periods").In 2011, the patient experienced anosmia ("2 years after insertion of essure she lost her sense of smell almost completely").In june 2013, the patient experienced pain in extremity ("right heel pain/toes pain/finger pain").In july 2013, the patient experienced back pain ("burning pain right lower back / back pain upper left") and muscle spasms ("muscle spasm in back").In november 2013, the patient experienced epicondylitis ("lateral epicondylitis of elbow").In january 2014, the patient experienced dyspnoea ("shortness of breath"), musculoskeletal pain ("pain in left scapular area / pain with deep breathing/shoulder pain") and muscle strain ("midback muscular strain").In february 2014, the patient experienced adnexa uteri pain ("ovarian pain"), abdominal pain lower ("right side lower abdomen pain"), polymenorrhoea ("menses every 2 weeks at times / irregular periods"), dysmenorrhoea ("painful periods"), libido decreased ("decreased libido") and pain ("body aches").In 2014, the patient experienced the first episode of fatigue ("fatigue").On an unknown date, the patient experienced the first episode of arthralgia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), metal poisoning (seriousness criterion medically significant) with feeling abnormal, vulval haemorrhage (seriousness criterion medically significant), complication of device removal ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), the second episode of fatigue ("general fatigue/fatigue"), insomnia ("hard time sleeping"), musculoskeletal stiffness ("residual effects like stiffness"), the second episode of arthralgia ("right elbow pain/ migrating arthritis-like pain all over her body/migrating joint pain/ inflammatory joint pain."), parosmia ("altered sense of smell / dysosmia"), anaemia ("anemia"), hypovitaminosis ("vitamin deficiencies"), blood disorder ("blood issues"), liver disorder ("liver issues"), abdominal pain ("cramping"), tooth loss ("tooth loss"), pelvic pain ("pain"), the first episode of neck pain ("pains that shoot up my neck"), oral pain ("pain that shoot up my neck into my mouth"), blood iron decreased ("iron low"), alopecia ("hair loss"), dysgeusia ("sensory disorder of taste"), pain in jaw ("all joints including jaws ") and the second episode of neck pain ("neck pain").The patient was treated with surgery and surgery (unilateral bilateral essure microsurgical removal on 31-03-2015).Essure was removed on (b)(6)2015.At the time of the report, the genital haemorrhage, the last episode of fatigue, insomnia, musculoskeletal stiffness, dyspnoea, parosmia and blood iron decreased had resolved, the autoimmune disorder, device breakage, metal poisoning, vulval haemorrhage, vaginal haemorrhage, complication of device removal, pain in extremity, back pain, muscle spasms, epicondylitis, musculoskeletal pain, muscle strain, adnexa uteri pain, abdominal pain lower, polymenorrhoea, dysmenorrhoea, libido decreased, pain, anaemia, hypovitaminosis, blood disorder, liver disorder, menorrhagia, abdominal pain, tooth loss, pelvic pain, oral pain, alopecia, dysgeusia, pain in jaw and the last episode of neck pain outcome was unknown and the anosmia had not resolved.The reporter provided no causality assessment for abdominal pain lower, adnexa uteri pain, back pain, complication of device removal, dyspnoea, epicondylitis, libido decreased, muscle spasms, muscle strain, musculoskeletal pain, pain, pain in extremity and parosmia with essure.The reporter considered abdominal pain, alopecia, anaemia, anosmia, autoimmune disorder, blood disorder, blood iron decreased, device breakage, dysgeusia, dysmenorrhoea, genital haemorrhage, hypovitaminosis, insomnia, liver disorder, menorrhagia, metal poisoning, musculoskeletal stiffness, oral pain, pain in jaw, pelvic pain, polymenorrhoea, tooth loss, vaginal haemorrhage, vulval haemorrhage, the first episode of arthralgia, the first episode of fatigue, the first episode of neck pain, the second episode of arthralgia, the second episode of fatigue and the second episode of neck pain to be related to essure.The reporter commented: on (b)(6)2016: surgical removal of coil(s) anothr dat were providede hysterectomy with bilateral salpingectomy cross referenced with case number : (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26 kg/sqm.Further company follow-up with the consumer, regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2018: plaintiff fact sheet, patient demographic information ,essure indication, permanent birth control by bilateral occlusion of the fallopian tubes, lot number,lab data and new event abnormal bleeding, abnormal bleeding,vaginal menorrhegea ), hair loss, low iron, dystocia and autoimmune disorder , all joints including jaws and neck pain,were added on(b)(6)2018: plaintiff fact sheet received: reporters details 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 the first episode of arthralgia ("crippling arthritic pain all over / joint pains in both arms and neck/ arthritis like pain in multiples parts of body./knee pain/ankle/wrists pain"), genital haemorrhage ("abnormal bleeding"), autoimmune disorder ("autoimmune disorder"), device breakage ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), metal poisoning ("heavy metal poisoning") and vulval haemorrhage ("vulval petechiae") in a 48-year-old female patient who had essure (batch no.710399) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2, gravida in (b)(6) 2008, abortion nos, hypothyroidism, familial risk factor, abstains from alcohol and nonsmoker.Previously administered products included for an unreported indication: toradol, levothyroxine, motrin and valium.Concurrent conditions included overweight.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding-vaginal menorrhegea )") and menorrhagia ("heavy periods").In 2011, the patient experienced anosmia ("2 years after insertion of essure she lost her sense of smell almost completely").In (b)(6) 2013, the patient experienced pain in extremity ("right heel pain/toes pain/finger pain").In (b)(6) 2013, the patient experienced back pain ("burning pain right lower back / back pain upper left") and muscle spasms ("muscle spasm in back").In (b)(6) 2013, the patient experienced epicondylitis ("lateral epicondylitis of elbow").In (b)(6) 2014, the patient experienced dyspnoea ("shortness of breath"), musculoskeletal pain ("pain in left scapular area / pain with deep breathing/shoulder pain") and muscle strain ("midback muscular strain").In (b)(6) 2014, the patient experienced adnexa uteri pain ("ovarian pain"), abdominal pain lower ("right side lower abdomen pain"), polymenorrhoea ("menses every 2 weeks at times / irregular periods"), dysmenorrhoea ("painful periods"), libido decreased ("decreased libido") and pain ("body aches").In 2014, the patient experienced the first episode of fatigue ("fatigue").On an unknown date, the patient experienced the first episode of arthralgia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), metal poisoning (seriousness criterion medically significant) with feeling abnormal, vulval haemorrhage (seriousness criterion medically significant), complication of device removal ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), the second episode of fatigue ("general fatigue/fatigue"), insomnia ("hard time sleeping"), musculoskeletal stiffness ("residual effects like stiffness"), the second episode of arthralgia ("right elbow pain/ migrating arthritis-like pain all over her body/migrating joint pain/ inflammatory joint pain."), parosmia ("altered sense of smell / dysosmia"), anaemia ("anemia"), hypovitaminosis ("vitamin deficiencies"), blood disorder ("blood issues"), liver disorder ("liver issues"), abdominal pain ("cramping"), tooth loss ("tooth loss"), pelvic pain ("pain"), the first episode of neck pain ("pains that shoot up my neck"), oral pain ("pain that shoot up my neck into my mouth"), blood iron decreased ("iron low"), alopecia ("hair loss"), dysgeusia ("sensory disorder of taste"), pain in jaw ("all joints including jaws ") and the second episode of neck pain ("neck pain").The patient was treated with surgery and surgery (unilateral bilateral essure microsurgical removal on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the genital haemorrhage, the last episode of fatigue, insomnia, musculoskeletal stiffness, dyspnoea, parosmia and blood iron decreased had resolved, the autoimmune disorder, device breakage, metal poisoning, vulval haemorrhage, vaginal haemorrhage, complication of device removal, pain in extremity, back pain, muscle spasms, epicondylitis, musculoskeletal pain, muscle strain, adnexa uteri pain, abdominal pain lower, polymenorrhoea, dysmenorrhoea, libido decreased, pain, anaemia, hypovitaminosis, blood disorder, liver disorder, menorrhagia, abdominal pain, tooth loss, pelvic pain, oral pain, alopecia, dysgeusia, pain in jaw and the last episode of neck pain outcome was unknown and the anosmia had not resolved.The reporter provided no causality assessment for abdominal pain lower, adnexa uteri pain, back pain, complication of device removal, dyspnoea, epicondylitis, libido decreased, muscle spasms, muscle strain, musculoskeletal pain, pain, pain in extremity and parosmia with essure.The reporter considered abdominal pain, alopecia, anaemia, anosmia, autoimmune disorder, blood disorder, blood iron decreased, device breakage, dysgeusia, dysmenorrhoea, genital haemorrhage, hypovitaminosis, insomnia, liver disorder, menorrhagia, metal poisoning, musculoskeletal stiffness, oral pain, pain in jaw, pelvic pain, polymenorrhoea, tooth loss, vaginal haemorrhage, vulval haemorrhage, the first episode of arthralgia, the first episode of fatigue, the first episode of neck pain, the second episode of arthralgia, the second episode of fatigue and the second episode of neck pain to be related to essure.The reporter commented: on (b)(6) 2016: surgical removal of coil(s) another date were provided hysterectomy with bilateral salpingectomy.Cross referenced with case number : (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 28-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 device breakage ('physician removed almost the entire essure device minus a small amount of stainless steel that he could not find'), genital haemorrhage ('abnormal bleeding'), autoimmune disorder ('autoimmune disorder'), metal poisoning ('heavy metal poisoning'), vulval haemorrhage ('vulval petechiae'), rheumatoid arthritis ('autoimmune disorder ¿ ra') and multiple episodes of arthralgia ('crippling arthritic pain all over / joint pains in both arms and neck/ arthritis like pain in multiples parts of body./knee pain/ankle/wrists pain', 'right elbow pain/ migrating arthritis-like pain all over her body/migrating joint pain/ inflammatory joint pain.') in a 48-year-old female patient who had essure (batch no.710399) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included skin lesion on (b)(6) 2016, skin disorder on (b)(6) 2016, gravida in (b)(6) 2008, multigravida, parity 2, abortion nos, hypothyroidism, familial risk factor, abstains from alcohol and nonsmoker.*toxic metals - lead 8.9 ug/g (normal range < 2 ug/g) ct sinuses cont.: minimal mucosal thickening.Previously administered products included for an unreported indication: toradol, levothyroxine, motrin and valium.Concurrent conditions included hyperopia since (b)(6) 2013, astigmatism since (b)(6) 2013, presbyopia since (b)(6) 2013, sinusitis chronic nos since (b)(6) 2012, rosacea since (b)(6) 2011 and overweight.Concomitant products included ferrous sulfate (ferosul) from (b)(6) 2009 to (b)(6) 2010, hydrocodone from (b)(6) 2009 to (b)(6) 2010, metronidazole from (b)(6) 2011 to (b)(6) 2013 and oxazepam from (b)(6) 2009 to (b)(6) 2010.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding9vaginal menorrhegea )") and menorrhagia ("heavy periods/menorrhagia ").In 2011, the patient experienced anosmia ("2 years after insertion of essure she lost her sense of smell almost completely").In (b)(6) 2012, the patient experienced alopecia ("hair loss").In (b)(6) 2013, the patient experienced rheumatoid arthritis (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced pain in extremity ("right heel pain/toes pain/finger pain").In (b)(6) 2013, the patient experienced back pain ("burning pain right lower back / back pain upper left") and muscle spasms ("muscle spasm in back").In (b)(6) 2013, the patient experienced epicondylitis ("lateral epicondylitis of elbow").In (b)(6) 2014, the patient experienced dyspnoea ("shortness of breath"), musculoskeletal pain ("pain in left scapular area / pain with deep breathing/shoulder pain") and muscle strain ("midback muscular strain").In (b)(6) 2014, the patient experienced adnexa uteri pain ("ovarian pain"), abdominal pain lower ("right side lower abdomen pain"), polymenorrhoea ("menses every 2 weeks at times / irregular periods"), dysmenorrhoea ("painful periods"), libido decreased ("decreased libido") and pain ("body aches").In 2014, the patient experienced the first episode of fatigue ("fatigue").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), the first episode of arthralgia (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), metal poisoning (seriousness criterion medically significant) with feeling abnormal, vulval haemorrhage (seriousness criterion medically significant), complication of device removal ("physician removed almost the entire essure device minus a small amount of stainless steel that he could not find"), the second episode of fatigue ("general fatigue/fatigue"), insomnia ("hard time sleeping"), musculoskeletal stiffness ("residual effects like stiffness"), the second episode of arthralgia ("right elbow pain/ migrating arthritis-like pain all over her body/migrating joint pain/ inflammatory joint pain."), parosmia ("altered sense of smell / dysosmia"), anaemia ("anemia"), hypovitaminosis ("vitamin deficiencies"), blood disorder ("blood issues"), liver disorder ("liver issues"), abdominal pain ("cramping"), tooth loss ("tooth loss"), pelvic pain ("pain"), neck pain ("pains that shoot up my neck"), oral pain ("pain that shoot up my neck into my mouth"), taste disorder ("sensory disorder of taste/smell"), pain in jaw ("all joints including jaws "), dental caries ("my dentist has found deep pockets in my molars") and gingival recession ("ihave noticed more recession") and was found to have blood iron decreased ("iron low").The patient was treated with surgery (unilateral bilateral essure microsurgical removal on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, autoimmune disorder, metal poisoning, vulval haemorrhage, vaginal haemorrhage, complication of device removal, pain in extremity, back pain, muscle spasms, epicondylitis, musculoskeletal pain, muscle strain, adnexa uteri pain, abdominal pain lower, polymenorrhoea, dysmenorrhoea, libido decreased, pain, anaemia, hypovitaminosis, blood disorder, liver disorder, menorrhagia, abdominal pain, tooth loss, pelvic pain, neck pain, oral pain, alopecia, taste disorder, pain in jaw, dental caries, gingival recession and rheumatoid arthritis outcome was unknown, the genital haemorrhage, the last episode of fatigue, insomnia, musculoskeletal stiffness, dyspnoea, parosmia and blood iron decreased had resolved and the anosmia had not resolved.The reporter provided no causality assessment for abdominal pain lower, adnexa uteri pain, back pain, complication of device removal, dyspnoea, epicondylitis, libido decreased, muscle spasms, muscle strain, musculoskeletal pain, pain, pain in extremity and parosmia with essure.The reporter considered abdominal pain, alopecia, anaemia, anosmia, autoimmune disorder, blood disorder, blood iron decreased, dental caries, device breakage, dysmenorrhoea, genital haemorrhage, gingival recession, hypovitaminosis, insomnia, liver disorder, menorrhagia, metal poisoning, musculoskeletal stiffness, neck pain, oral pain, pain in jaw, pelvic pain, polymenorrhoea, rheumatoid arthritis, taste disorder, tooth loss, vaginal haemorrhage, vulval haemorrhage, the first episode of arthralgia, the first episode of fatigue, the second episode of arthralgia and the second episode of fatigue to be related to essure.The reporter commented: on (b)(6) 2016: surgical removal of coil(s) anothr dat were providede hysterectomy with bilateral salpingectomy cross referenced with case number : (b)(4).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26 kg/sqm.Computerised tomogram - on (b)(6) 2009: results: total bilateral occlusion; on (b)(6) 2012: results: small left maxillary likely mucous retention cyst.Hysterosalpingogram - on (b)(6) 2009: results: satisfactory placement/ both tubes full occulsion.Magnetic resonance imaging brain - on (b)(6) 2012: results: minimal chronic sinus disease.Concerning the injuries reported in this case, the following one/ones were reported via social media: dental caries and gingival recession.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, regulatory authority, consumer, consumer or consumer is not possible.Most recent follow-up information incorporated above includes: on 11-nov-2019: pfs received: new events added: autoimmune disorder ¿ ra.Reporter information were updated.Patient history, concomitant drugs were added.Incident we received a lot number.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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