Patient continued to ooze around the jada [device ineffective].Case narrative: this initial spontaneous report originating from the united states was received from a physician who overheard the information from one of her colleagues, via clinical education specialist referring to a non-pregnant female patient of unknown age.The patient's medical history included in vitro fertilization (ivf), and pregnancy with a vaginal delivery.The patient's concurrent conditions, past drug reactions/allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intrauterine route by provider for postpartum hemorrhage however patient continued to ooze around the vacuum-induced hemorrhage control system (jada system) (device ineffective).Ten minutes after being connected to vacuum, unknown setting, provider removed vacuum-induced hemorrhage control system (jada system) and chose to put in bakri balloon which was effective.The patient sought medical attention.No additional information was known or available.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event device ineffective was determined to be serious due to required intervention.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).
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