But did not work properly [device ineffective].As the blood kept clotting behind the device [device occlusion].Case narrative: the spontaneous report was received from a nurse via field-based employee referring to non-pregnant female patient of unknown age.The patient historical condition included anemia with no history of post-partum hemorrhage, scheduled cesarean section (c-section) with spinal, gravida 2 and para 1 (g2 p1) with a singleton pregnancy.The patient¿s concurrent condition included hospitalization.The patient¿s concomitant medication included oxytocin (reported as oxytocin bolus) and methylergometrine maleate (methergine).The patient¿s historical medications, and past drug reactions/allergies were not reported.This report concerned 1 patient and 2 devices.On (b)(6) 2022 (also reported late yesterday afternoon), the patient was inserted with vacuum-induced hemorrhage control system (jada system 1 and 2) via intravaginal route (lot# and expiration date was not reported) for an unknown indication.It was reported patient gestation period was unknown and was no invasive placenta.Patient uterus was ¿swept¿ prior to incision closed.The reporter stated, patient noticed 2 devices were placed separately after a c-section (cesarean section) but did not work properly (drug ineffective) as the blood kept clotting behind the device (device occlusion).The patient was hospitalized due the events.Two vacuum-induced hemorrhage control system (jada system 1 and 2) were utilized and neither device controlled the bleeding due to blood clotting behind the device and the patient underwent a full hysterectomy.The patient required maternal admission to intensive care unit (icu) overnight until patient was hemodynamically stable due to which blood products were required however, blood type and volume were unknown.The reporter had no other details at this time and stated she had reached out to the nurse educator and had not heard back.It was reported the patient was not died.The patient sought for medical attention.No product quality compliant (pqc) were reported.Upon internal review, the events drug ineffective and device occlusion were considered to be serious as it required surgical intervention.Medical device reporting criteria: serious injury.(b)(4).
|