Jada did not control the bleeding [device ineffective].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical account specialist (cas), referring to a female patient of unknown age.The patient's historical conditions were considered as singleton pregnancy and emergent c-section.Reportedly, the patient was in labor for 3 days.She was gravida 1, para 1 (g1p1).Her current condition also included uterine atony and hospitalization.Patient lost 3200 ml of blood prior to vacuum-induced hemorrhage control system (jada system) insertion.Her past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for postpartum hemorrhage.Reportedly, the device came with a blue seal valve.However, the vacuum-induced hemorrhage control system (jada system) did not control the bleeding (device ineffective) and in total the patient lost 8000 ml of blood.The device was removed on the same day.The patient required intensive care unit (icu) admission (considered as prolonged hospitalization) which was ongoing at the time of reporting.The suspected cause of postpartum hemorrhage was reported as uterine atony.Reportedly, the patient sought medical attention and received treatment (discrepancy).More than one device was not used.No additional information was available.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.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.
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