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Patient had suffered a cervical laceration [uterine cervical laceration] off label use/patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy [device placement issue].Off label use/patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy [off label use].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified nurse via clinical account specialist (cas), referring to a female patient of unknown age.The patient's historical conditions included pregnancy and cesarean section.Her concurrent conditions included hospitalization.Her historical drugs, concomitant drugs and allergies were not reported.This report concerns 1 patient and 1 device.On an unknown date, the physician attempted to insert vacuum-induced hemorrhage control system (jada system) but noted that the patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy (device placement issue, and off label use) (discrepant information: route was also reported as intravaginal) for postpartum hemorrhage.It was reported to work for a while until it was discovered that the patient had suffered a cervical laceration (uterine cervical laceration) and therefore, the hospitalization was prolonged.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.The outcome of uterine cervical laceration was unknown.The causality assessment was not reported.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).
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Patient had suffered a cervical laceration [uterine cervical laceration].The jada device did not stop control the bleeing [device ineffective].Off label use/patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy [device placement issue].Off label use/patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy [off label use].Case narrative: this initial spontaneous report originating from the united states was received from an unspecified nurse via clinical account specialist (cas), referring to a female patient of unknown age.The patient's historical conditions included pregnancy and cesarean section.Her concurrent conditions included hospitalization.Her historical drugs, concomitant drugs and allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the physician attempted to insert vacuum-induced hemorrhage control system (jada system) but noted that the patient was not dilated enough, so he attempted to dilate her manually, but was unsuccessful.The device was then inserted via the hysterotomy (device placement issue, and off label use) (discrepant information: route was also reported as intravaginal) for postpartum hemorrhage.It was reported to work for a while until it was discovered that the patient had suffered a cervical laceration (uterine cervical laceration) and therefore, the hospitalization was prolonged.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.The outcome of uterine cervical laceration was unknown.The causality assessment was not reported.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4607 hospitalization or prolonged hospitalization (hospitalization or prolonged hospitalization due to the health damage accompanying the use of device).Follow-up information was received from a physician on 20-jul-2023.The physician reported that the patient had a history of postpartum hemorrhage with her first delivery, and two prior caesarean sections.Her latest (reported as current) pregnancy was singleton, and delivery was scheduled caesarean at 39 weeks of gestation.The delivery was not induced.Her gravida and para were reported as 3 each.No agents were used, and there was no invasive placenta, endometritis, disseminated intravascular coagulation (dic), or hyperglycemia at admission or at discharge.Prior to vacuum-induced hemorrhage control system (jada system), she was given oxytocin (pitocin), methylergometrine maleate (methergine) and red blood cells, concentrated (reported as packed red blood cells) (during peripartum period) (all considered as concomitant medication).The estimated blood loss prior to device use was 1100 ml, and estimated total blood loss at delivery was 2000 ml.It was reported that the vacuum-induced hemorrhage control system (jada system) came with a white carton.The start date of the device and onset date of all the events was updated as an unknown date in 2023 (reported as "several weeks ago").It was reported that the vacuum-induced hemorrhage control system (jada system) did not stop control the bleeding (device ineffective, onset date: unknown date in 2023) and the patient ended up having hysterectomy.Reportedly, the device worked without issue, but the bleeding continued.More than one device was not used, and the device was not removed and then reinserted for any reason.An ultrasound was not used to evaluate the device use.It wasn't the physician's first time using the device.Maternal admission to the intensive care unit (icu) was not required.The abnormal postpartum hemorrhage was controlled by hysterectomy, and the suspected cause of postpartum hemorrhage was uterine atony (considered as current condition) (discrepancy; also reported that lower uterine segment atony was not involved).Upon internal review, the event of uterine cervical laceration and device ineffective was considered as serious for the following seriousness criteria: prolonged hospitalization and required intervention.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).
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