It did not work [device ineffective] no additional adverse event/ product quality complaint (ae/pqc) identified.[no adverse event].Case narrative: this spontaneous report originating from united states was received from a female patient (consumer) of unknown age via (b)(6) employee, referring to herself.The patient¿s historical condition, current condition, concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via vaginal route (defaulted) (lot# and expiration date were not reported) for an unknown indication.The patient stated that her insurance was not covering the placement of the vacuum-induced hemorrhage control system (jada system), though it did not work (device ineffective) and she had to take place additional interventions to save her life.She would like a refund.No additional adverse event/ product quality complaint (ae/pqc) (no adverse event) identified.Therapy with vacuum-induced hemorrhage control system (jada system) was not applicable.The outcome of event device ineffective was unknown.Upon internal review, the event device ineffective was determined to be serious to due required intervention (devices).When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).
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