| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Incorrect, Inadequate or Imprecise Result or Readings (1535); Microbial Contamination of Device (2303); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Bacterial Infection (1735); Pain (1994); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Foreign Body In Patient (2687); Pregnancy (3193)
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| Event Date 08/01/2012 |
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Event Type
Injury
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Event Description
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This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic infection ("infections"), device dislocation ("migration of one essure coil / migrated coils could not be located") and pregnancy with contraceptive device ("pregnancy") in a female patient who received essure for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective ("device ineffective").On (b)(6) 2010, the patient started essure.The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date.The patient received essure during the first trimester of pregnancy.On an unknown date, the patient experienced pelvic infection (serious criteria medically significant and clinically significant/intervention required), device dislocation (serious criterion medically significant), pregnancy with contraceptive device (serious criterion medically significant), pelvic pain ("severe pelvic pain") and abdominal pain ("abdominal pain").At the time of the report, the pelvic infection and pelvic pain had not resolved and the device dislocation, pregnancy with contraceptive device and abdominal pain outcome was unknown.The pregnancy outcome was not reported.The reporter considered pelvic infection, device dislocation, pregnancy with contraceptive device, pelvic pain and abdominal pain to be related to essure.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although, we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are known, possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 14-dec-2016: quality safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced migration of one essure coil/migrated coils could not be located (device dislocation), leading to pregnancy (as per reporter) and infections (seen as pelvic infection).Pelvic infection, device dislocation, and pregnancy with contraceptive device are anticipated in the reference safety information for essure.Although essure system is sterile, it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract, leading to an increased risk for pelvic infections after insertion procedure.Therefore, a causal relationship between the reported infections and essure inserts cannot be excluded.Considering that essure may move during therapy and that a dislocated essure may contribute to pregnancy, a causal relationship between these events and essure inserts cannot be excluded.This case is regarded as incident due to serious injury related to essure.A product quality defect could not be confirmed but is considered plausible.Further information has been requested.
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Manufacturer Narrative
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This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic infection ("infections"), device dislocation ("migration of one essure coil / migrated coils could not be located / right coil migration/ malposition of essure device (location of device: left side migrating) / migration of essure device (location of device: left side migrating)"), uterine perforation ("perforation (uterus)"), fallopian tube perforation ("perforation (fallopian tube(s) / right coil migration/perforation of device"), pregnancy with contraceptive device ("pregnancy / pregnancy (with complications) - intrauterine pregnancy at term"), polyhydramnios ("pregnancy (with complications) - polyhydramnios") and premature rupture of membranes ("pregnancy (with complications) - premature rupture of membranes failed tubal") in a 42-year-old female patient (gravida 5, para 4) who had essure (batch no.766623) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective / failure to occlude (close) fallopian tube(s)" in 2010 and device monitoring procedure not performed "she did not undergo essure confirmation test.".The patient's past medical history included multi gravida, multiparous ((b)(6) 1995, (b)(6) 2000, (b)(6) 2010, (b)(6) 2012), pelvic adhesions (approximately (b)(6) 2010) on (b)(6) 2010, fibroids (approximately (b)(6) 2010) on (b)(6) 2010 and cesarean section (the patient at the time of surgery was noted to have extensive scaring and adhesions making the csection at that time very difficult.The bilateral fallopian tubes were not able to be adequately visualized at the time of csection.Due to this, the patient has presented today for an essure tubal occlusion.).Concomitant products included venlafaxine since 2015 for anxiety and depression, amlodipine besilate (amlodipine besylate) since 2015, hydralazine since 2015, lisinopril since 2015 and metoprolol since 2015 for blood pressure high, gabapentin since 2015 for seizures as well as cream (do no recall type) and hydrochlorothiazide since 2015.In 2010, the patient experienced bacterial vaginosis ("infection (bacterial vaginosis)") with vaginal discharge and vulvovaginal mycotic infection ("infection (vaginal yeast)").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2012, 1 year 10 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant), polyhydramnios (seriousness criterion medically significant) and premature rupture of membranes (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, abdominal pain and abdominal pain lower, fallopian tube perforation (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia, dyspareunia (painful sexual intercourse)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)") and single umbilical artery ("two-vessel cord").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first and second trimesters of pregnancy.The patient was treated with co-trimoxazole (bactrim), ibuprofen (motrin), surgery, surgery and surgery (cesarean section.).Essure was removed.At the time of the report, the pelvic infection had not resolved and the device dislocation, uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, polyhydramnios, premature rupture of membranes, bacterial vaginosis, dyspareunia, menorrhagia, vaginal haemorrhage, migraine, headache, nausea, dysmenorrhoea, vulvovaginal mycotic infection and single umbilical artery outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.The caesarean delivery occurred on (b)(6) 2012.The reporter considered bacterial vaginosis, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, headache, menorrhagia, migraine, nausea, pelvic infection, polyhydramnios, pregnancy with contraceptive device, premature rupture of membranes, single umbilical artery, uterine perforation, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: the essure apparatus was deployed and one coil was visualized after deployment of the essure device.Healthcare provider concerning removal of essure device as device migrated and would require a partial hysterectomy to remove.Diagnostic results: on (b)(6) 2012 : ob ultrasound transabdominal : transabdominal imaging of the fetus demonstrates a single intrauterine gestation which is by dates 18 weeks and 4 days.By ultrasound parameters, it is 19 weeks and 1 day.It is associated with posterior placenta with normal amniotic fluid and a grade 0 placenta.The fetus is in cephalic presentation and demonstrates a three-vessel cord.By growth parameters, the fetus is at 19 weeks and 1 day and the heart rate is identified at 145 beats per minute.On (b)(6) 2012 : surgical pathology consultation : the specimen is received in formalin, labeled with the patient's name, designated as "placenta.¿¿ it consists of a 20.5 x 18.0 x 2.8 cm somewhat disrupted placenta with gross greenish brown staining of the dull placental membranes.The point of rupture is at the placental margin.The cotyledons show disruption at near the point of membrane rupture.The umbilical cord stump is 15.0 cm in length.It is free of knots or kinks, and it shows only two vessels on cut surface.The umbilical cord is also stained greenish brown.Sections of umbilical cord are submitted labeled a.Sections of membranes are submitted labeled b.The trimmed, fixed placental disc weighs 550 g.The fetal surface is dull and greenish tan due to the gross meconium staining.The maternal surface shows extensive tearing and disruption of the cotyledons as described before.The cut surface is soft, dark red, and spongy.In some areas, the periphery shows thinning of the placenta.On (b)(6) 2016 : pelvic ultrasound : uterus is mildly enlarged.Linear echogenicity is noted in the left infundibulum consistent with proper essure devic8 placement.Essure device is not identified in the right infundibular area.Instead, there is a linear echogenicity in the cervix which may represent either migrated essure device rim properly placed essure devices.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although, we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are known, possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 22-feb-2018: medical records and plaintiff fact sheet :pregnancy ((with complications) : intrauterine pregnancy atterm, premature rupture of membranes failed tubal, two-vessel cord, polyhydramnios.Vaginal discharge, bacterial vaginosis, vaginal yeast, failure to occlude, pain, right coil migration/perforation of device, dyspareunia, abnormal bleeding (vaginal, menorrhagia), infection (bacterial vaginosis, vaginal yeast), malposition of essure device (location of device: left side migrating), migraines/headaches, migration of essure device (location of device: left side migrating), nausea, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), failure to occlude (close) fallopian tube(s), perforation (fallopian tube(s)), perforation (uterus), sporadic (dull or sharp) daily left lower quadrant pain, sporadic (dull or sharp) daily abdominal pain added as events.Lab data added ¿essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only¿ incident: 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 prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic infection ("infections"), device dislocation ("migration of one essure coil / migrated coils could not be located / right coil migration/ malposition of essure device (location of device: left side migrating) / migration of essure device (location of device: left side migrating)"), uterine perforation ("perforation (uterus)"), fallopian tube perforation ("perforation (fallopian tube(s) / right coil migration/perforation of device"), pregnancy with contraceptive device ("pregnancy / pregnancy (with complications) - intrauterine pregnancy at term"), polyhydramnios ("pregnancy (with complications) - polyhydramnios") and premature rupture of membranes ("pregnancy (with complications) - premature rupture of membranes failed tubal") in a 42-year-old female patient (gravida 5, para 4) who had essure (batch no.766623) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective / failure to occlude (close) fallopian tube(s)" in 2010 and device monitoring procedure not performed "she did not undergo essure confirmation test.".The patient's past medical history included multi gravida, parity 4 (b)(6)1995, (b)(6)2000, (b)(6)2010, (b)(6)2012), pelvic adhesions (approximately (b)(6)2010) on (b)(6)2010, fibroids (approximately (b)(6)2010) on (b)(6)2010 and multiple cesarean sections (the patient at the time of surgery was noted to have extensive scaring and adhesions making the csection at that time very difficult.The bilateral fallopian tubes were not able to be adequately visualized at the time of csection.Due to this, the patient has presented today for an essure tubal occlusion.).Concomitant products included venlafaxine since 2015 for anxiety and depression, amlodipine besilate (amlodipine besylate) since 2015, hydralazine since 2015, lisinopril since 2015 and metoprolol since 2015 for blood pressure high, dermatologicals for eczema, gabapentin since 2015 for seizures as well as hydrochlorothiazide since 2015.In 2010, the patient experienced bacterial vaginosis ("infection (bacterial vaginosis)") with vaginal discharge and vulvovaginal mycotic infection ("infection (vaginal yeast)").On (b)(6)2010, the patient had essure inserted.On (b)(6)2012, 1 year 10 months after insertion of essure, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant), polyhydramnios (seriousness criterion medically significant) and premature rupture of membranes (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, abdominal pain and abdominal pain lower, fallopian tube perforation (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia, dyspareunia (painful sexual intercourse)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headaches"), nausea ("nausea") and dysmenorrhoea ("dysmenorrhea (cramping)").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first and second trimesters of pregnancy.The patient was treated with co-trimoxazole (bactrim), ibuprofen (motrin), surgery, surgery and surgery (cesarean section.).Essure was removed.At the time of the report, the pelvic infection had not resolved and the device dislocation, uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, polyhydramnios, premature rupture of membranes, bacterial vaginosis, dyspareunia, menorrhagia, vaginal haemorrhage, migraine, headache, nausea, dysmenorrhoea and vulvovaginal mycotic infection outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.The caesarean delivery occurred on (b)(6)2012.The reporter considered bacterial vaginosis, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, headache, menorrhagia, migraine, nausea, pelvic infection, polyhydramnios, pregnancy with contraceptive device, premature rupture of membranes, uterine perforation, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: the essure apparatus was deployed and one coil was visualized after deployment of the essure device.Healthcare provider concerning removal of essure device as device migrated and would require a partial hysterectomy to remove.This mother case 2016-231367 is linked with child case 2018-049321 diagnostic results: on (b)(6)2012 : ob ultrasound transabdominal : transabdominal imaging of the fetus demonstrates a single intrauterine gestation which is by dates 18 weeks and 4 days.By ultrasound parameters, it is 19 weeks and 1 day.It is associated with posterior placenta with normal amniotic fluid and a grade 0 placenta.The fetus is in cephalic presentation and demonstrates a three-vessel cord.By growth parameters, the fetus is at 19 weeks and 1 day and the heart rate is identified at 145 beats per minute.On (b)(6)2012 : surgical pathology consultation : the specimen is received in formalin, labeled with the patient's name, designated as "placenta.¿¿ it consists of a 20.5 x 18.0 x 2.8 cm somewhat disrupted placenta with gross greenish brown staining of the dull placental membranes.The point of rupture is at the placental margin.The cotyledons show disruption at near the point of membrane rupture.The umbilical cord stump is 15.0 cm in length.It is free of knots or kinks, and it shows only two vessels on cut surface.The umbilical cord is also stained greenish brown.Sections of umbilical cord are submitted labeled a.Sections of membranes are submitted labeled b.The trimmed, fixed placental disc weighs 550 g.The fetal surface is dull and greenish tan due to the gross meconium staining.The maternal surface shows extensive tearing and disruption of the cotyledons as described before.The cut surface is soft, dark red, and spongy.In some areas, the periphery shows thinning of the placenta.On (b)(6)2016 : pelvic ultrasound : uterus is mildly enlarged.Linear echogenicity is noted in the left infundibulum consistent with proper essure devic8 placement.Essure device is not identified in the right infundibular area.Instead, there is a linear echogenicity in the cervix which may represent either migrated essure device rim properly placed essure devices.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although, we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events or lack of efficacy cannot be totally excluded.However, the medical events and lack of efficacy are known, possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 22-feb-2018: case correction done.Event two vessel cord was deleted.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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Spective pregnancy case was reported by a lawyer and describes the occurrence of pelvic infection ("infections"), device dislocation ("migration of one essure coil / migrated coils could not be located / right coil migration/ malposition of essure device (location of device: left side migrating) / migration of essure device (location of device: left side migrating)"), uterine perforation ("perforation (uterus)"), fallopian tube perforation ("perforation (fallopian tube(s) / right coil migration/perforation of device"), pregnancy with contraceptive device ("pregnancy / pregnancy (with complications) - intrauterine pregnancy at term"), polyhydramnios ("pregnancy (with complications) - polyhydramnios") and premature rupture of membranes ("pregnancy (with complications) - premature rupture of membranes failed tubal") in a 41-year-old female patient (gravida 5, para 4) who had essure (batch no: 766623-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective / failure to occlude (close) fallopian tube(s)" in 2010 and device monitoring procedure not performed "she did not undergo essure confirmation test." the patient's past medical history included multi gravida, parity 4 (on (b)(6) 1995, on (b)(6)2000, on (b)(6) 2010, on (b)(6) 2012), pelvic adhesions (approximately on (b)(6) 2010) on (b)(6) 2010, fibroids (approximately on (b)(6) 2010) on (b)(6) 2010 and multiple cesarean sections (the patient at the time of surgery was noted to have extensive scaring and adhesions making the csection at that time very difficult.The bilateral fallopian tubes were not able to be adequately visualized at the time of csection.Due to this, the patient has presented today for an essure tubal occlusion.).Concomitant products included venlafaxine since 2015 for anxiety and depression, amlodipine besilate (amlodipine besylate) since 2015, hydralazine since 2015, lisinopril since 2015 and metoprolol since 2015 for blood pressure high, dermatologicals for eczema, gabapentin since 2015 for seizures as well as hydrochlorothiazide since 2015.In 2010, the patient experienced bacterial vaginosis ("infection (bacterial vaginosis)") with vaginal discharge and vulvovaginal mycotic infection ("infection (vaginal yeast)").On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2012, 1 year 10 months after insertion of essure, the patient experienced polyhydramnios (seriousness criterion medically significant) and premature rupture of membranes (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, abdominal pain and abdominal pain lower, fallopian tube perforation (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia, dyspareunia (painful sexual intercourse)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headaches"), nausea ("nausea") and dysmenorrhoea ("dysmenorrhea (cramping)").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first and second trimesters of pregnancy.The patient was treated with co-trimoxazole (bactrim), ibuprofen (motrin), surgery, surgery and surgery (cesarean section.).Essure was removed.At the time of the report, the pelvic infection had not resolved and the device dislocation, uterine perforation, fallopian tube perforation, pregnancy with contraceptive device, polyhydramnios, premature rupture of membranes, bacterial vaginosis, dyspareunia, menorrhagia, vaginal haemorrhage, migraine, headache, nausea, dysmenorrhoea and vulvovaginal mycotic infection outcome was unknown.The pregnancy outcome was reported as a live birth of a child with health problems.The caesarean delivery occurred on (b)(6) 2012.The reporter considered bacterial vaginosis, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, headache, menorrhagia, migraine, nausea, pelvic infection, polyhydramnios, pregnancy with contraceptive device, premature rupture of membranes, uterine perforation, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: the essure apparatus was deployed and one coil was visualized after deployment of the essure device.Healthcare provider concerning removal of essure device as device migrated and would require a partial hysterectomy to remove.This mother case: (b)(4) is linked with child case: (b)(4).Diagnostic results: on (b)(6) 2012 : ob ultrasound transabdominal : transabdominal imaging of the fetus demonstrates a single intrauterine gestation which is by dates 18 weeks and 4 days.By ultrasound parameters, it is 19 weeks and 1 day.It is associated with posterior placenta with normal amniotic fluid and a grade 0 placenta.The fetus is in cephalic presentation and demonstrates a three-vessel cord.By growth parameters, the fetus is at 19 weeks and 1 day and the heart rate is identified at 145 beats per minute.On (b)(6) 2012 : surgical pathology consultation : the specimen is received in formalin, labeled with the patient's name, designated as "placenta.¿¿ it consists of a 20.5 x 18.0 x 2.8 cm somewhat disrupted placenta with gross greenish brown staining of the dull placental membranes.The point of rupture is at the placental margin.The cotyledons show disruption at near the point of membrane rupture.The umbilical cord stump is 15.0 cm in length.It is free of knots or kinks, and it shows only two vessels on cut surface.The umbilical cord is also stained greenish brown.Sections of umbilical cord are submitted labeled a.Sections of membranes are submitted labeled b.The trimmed, fixed placental disc weighs 550 g.The fetal surface is dull and greenish tan due to the gross meconium staining.The maternal surface shows extensive tearing and disruption of the cotyledons as described before.The cut surface is soft, dark red, and spongy.In some areas, the periphery shows thinning of the placenta.On (b)(6) 2016 : pelvic ultrasound : uterus is mildly enlarged.Linear echogenicity is noted in the left infundibulum consistent with proper essure devic8 placement.Essure device is not identified in the right infundibular area.Instead, there is a linear echogenicity in the cervix which may represent either migrated essure device rim properly placed essure devices.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-jul-2018: quality safety evaluation of product technical complaint.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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Search Alerts/Recalls
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