Jada system did not work [device ineffective].Case narrative: this spontaneous report originating from united states was received from a physician via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history, past drugs/ allergies and concomitant medications were not reported.At the time of reporting, the patient was not pregnant.This report concerns 1 patient and 1 device.The physician reported that her colleagues (unspecified) stated that on an unknown date, there was an instance when the patient was inserted with vacuum-induced hemorrhage control system (jada system), intravaginally for postpartum hemorrhage, by an unspecified healthcare provider, however, the vacuum-induced hemorrhage control system (jada system) did not work (device ineffective) and her healthcare provider had to use surgical interventions (unspecified).Reportedly, medical attention was requested.No further details were available at the time of reporting.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.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.Therefore, priority quality investigation will not be completed.Medical device reporting criteria: serious injury.This was one of the six reports received from the same reporter.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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