The jada system was not successful at controlling the bleeding / did the jada device stop control the bleeding? no [device ineffective].Case narrative: this initial spontaneous report originating from united states was received from a nurse via clinical educator referring to a female patient of unknown age.The patient's historical condition included pregnancy (discrepant information provided: "it was reported that the patient was currently pregnant").The patient's concomitant medications, and drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.Approximately on an unknown date in 2022 (reported as within the last six weeks), the patient underwent vacuum-induced hemorrhage control system (jada system) placement for abnormal postpartum uterine bleeding or hemorrhage (postpartum haemorrhage) (lot# was not reported).It was reported that vacuum-induced hemorrhage control system (jada system) came in a blue seal valve, kit and green carton.It was reported that vacuum-induced hemorrhage control system (jada system) was not successful at controlling the bleeding (device ineffective) and had to be discontinued.The nurse manager stated that she believed the problem was provider education issues.It was reported that not more than one vacuum-induced hemorrhage control system (jada system) was used.No other symptoms were reported for the patient.No additional information was provided.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event device ineffective was considered to be medically significant.This is one of 2 reports received from the same reporter.Medical device reporting criteria: serious injury.
|