Patient continued to "bleed heavily and fast around the seal" [device ineffective].Case narrative: this initial spontaneous report originating from the united states, was received from a physician via company representative referring to a female patient of unknown age.The patient's current condition included uterine atony, and historical condition included pregnancy and vaginal birth (reported as unsure).Her concomitant drugs included "all the uterotonics" (further unspecified).Her historical drugs and allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via an unknown route (lot # and expiration date were not reported) for abnormal postpartum uterine bleeding (postpartum haemorrhage) by the physician, with the suction set at 80 mmhg and 120 ml in the cervical seal, however, the patient continued to "bleed heavily and fast around the seal" (device ineffective).The patient ended up with a hysterectomy.The suspected cause of postpartum haemorrhage was uterine atony.No other information or details were known or available at the time of reporting.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device ineffective was determined to be serious as it required intervention.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): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).
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