Device was working successfully, tone was returned to uterus, but a few minutes later it was noted the patient was having vaginal bleeding around the device and the uterus lost tone [device effect incomplete].Case narrative: this initial spontaneous report originating from united states was received from a nurse manager via clinical educator referring to a non-pregnant female patient of unknown age.This report concerns 1 patient and 1 device.The patient¿s medical history included pregnancy and the patient was admitted for scheduled caesarean section (c-section), reason was unknown, was 6 centimeters (cm) dilated but not in active labor.The c-section performed without any issues and delivery was not induced, but the patient started bleeding and multiple unknown medications were administered in an attempt to slow bleeding unsuccessfully.The reporter stated the chart showed the patient had estimated blood loss (ebl) between 4000-5000 milliliter (ml) prior to the insertion of vacuum-induced hemorrhage control system (jada system) device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via intravaginal route for postpartum hemorrhage (postpartum haemorrhage).The amount of fluid placed in vaginal seal was unknown.The nurse manager stated that the device was working successfully, tone was returned to uterus but a few minutes later it was noted the patient had vaginal bleeding around the device and the uterus lost tone (device effect incomplete).The blood collected in the vacuum-induced hemorrhage control system (jada system) canister was 110 ml.The nurse manager stated no trouble shooting techniques were performed.It was reported that at some point prior to hysterectomy the patient did receive blood products, amount, and exact product unknown.The nurse manager also stated she did not know the patient¿s platelet count.The patient ended up having hysterectomy.The patient sought medical attention.The patient did not die.The device was not removed and was not reinserted for any reason.It was reported that more than one vacuum-induced hemorrhage control system (jada system) was not used.On an unknown date, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.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 of device effect incomplete was considered as serious due to required intervention.Medical device reporting criteria: (b)(4).
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