Jada attempted and controlled bleeding briefly/bleeding did not subside after 5-10 minutes of insertion [device ineffective].Case narrative: this initial solicited report was received from a physician referring to a non-pregnant female patient of unknown age who was enrolled in a market research program entitled "jada drivers & barriers qualitative market research" conducted by trinity life sciences.The patient's medical history included pregnancy and had a delivery via c-section (caesarean section), her concurrent conditions and drug reactions/allergies were not reported.The patient's concomitant medications included oxytocin (pitocin) and methylergometrine maleate (methergine).This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (device number 1) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).The physician reported that the patient was not her patient, and it was her partner who said to her about the patient.It controlled bleeding briefly (also reported as ¿bleeding did not subside after 5-10 minutes of insertion¿ and ¿vacuum-induced hemorrhage control system (jada system) (device 1) did not control the bleeding (continued uterine bleeding)¿) (device ineffective).The vacuum-induced hemorrhage control system (jada system) (device number 1) was removed and replaced with a new vacuum-induced hemorrhage control system (jada system) (device number 2) which also briefly controlled bleeding (captured in oars# o2303usa001414) and then bleeding resumed.It was reported that bakri placed, and bleeding continued, to hysterectomy which resolved the bleeding.The patient sought medical attention and received treatment (discrepancy: also reported as prescription drug treatment for experience was not required).The patient did not die, no prolonged hospitalization, and no significant disability or incapacity was reported.The vacuum-induced hemorrhage control system (jada system) (device number 1) was not available for evaluation since it was disposed of after use.For vacuum-induced hemorrhage control system (jada system) (device number 1), lot number and serial number were not available
upon internal review, the event of device ineffective was considered as serious due to required intervention.This case has been cross referenced with oars# (b)(4) (same patient)
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).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).The follow-up information has been submitted to the original case, oars# (b)(4).
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