Three unknown providers attempted to insert jada (unknown if one or three different jada devices used) but they "couldn't get it to work/the jada device stop control the bleeding [device ineffective] device would not work due to the retroverted uterus and the patients anatomy [contraindicated device used] case narrative: this spontaneous report originating from united states was received from nurse via field representative, referring to a female patient of unknown age.On an unknown date in 2022, the patient became pregnant.On an unknown date in (b)(6) 2023, the patient gave birth to twins via cesarean section by 4-centimeter (cm) dilatation.During cesarean section, it was observed that patient had retroverted uterus and the retroverted uterus was not surgically corrected as the patient was not considered to have any risk factors.After the cesarean section, the patient started bleeding.The patient's concomitant medications and drug reactions / allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date in (b)(6) 2023, the patient had vacuum-induced hemorrhage control system (jada system) insertion (lot# and expiration date were not reported) for bleeding (postpartum haemorrhage) by three unknown providers (health care professional).It was unknown if one or three different vacuum-induced hemorrhage control system (jada system) devices used but they could not get it to work, and the vacuum-induced hemorrhage control system (jada system) device did not stop control the bleeding (device ineffective).The providers then followed escalating treatment which was required after vacuum-induced hemorrhage control system (jada system) use to control abnormal postpartum uterine bleeding or hemorrhage and inserted bakri uterine balloon tamponade by surgical intervention which also failed.It was reported that the device would not work due to the retroverted uterus and the patient's anatomy (contraindicated device used).The reporter did not know if any other interventions were attempted or the outcome for the patient.No additional information provided.No additional adverse event (ae)/ product quality complaint (pqc) reported.For vacuum-induced hemorrhage control system (jada system), the lot number is not available, and the serial number is not available.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn on an unknown date in (b)(6) 2023.The outcome of device ineffective and contraindicated device used was unknown.The reporter's causality assessment was not provided.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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