This initial spontaneous report originating from the united states was received from a physician via employee referring to a female patient of unknown age.Patient delivered twins on an unknown date in (b)(6) 2022 (reported as approximately 2 weeks ago) (unknown delivery method).Information regarding the patient's other medical history, concurrent conditions and concomitant medications were not provided.This report concerns 1 device and 1 patient.On an unknown date in (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post-partum hemorrhaging.Employee stated that vacuum-induced hemorrhage control system (jada system) was unable to control bleeding (device ineffective) as they "could not get the device to stay in place" (device expulsion).After vacuum-induced hemorrhage control system (jada system) was removed, bakri balloon (also reported as bakri uterine balloon) was inserted.Employee had extremely limited details and had reached out to the customer via email for additional details.No additional information available at that time.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The event device ineffective was considered as serious as it required intervention with an escalating treatment.Upon internal review, the event of "device expulsion" was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: (b)(4).
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