It was clogged up with clots and another physician came in to place the 2nd jada system [device occlusion].She didn¿t think the patient was dilated 3cm, but she said the physician said the patient was dilated 3cm".[wrong technique in device usage process].Case narrative: this initial spontaneous report originating from the united states, was received from a company representative via nurse, referring to a female patient of unknown age.The patient¿s current conditions, medical history and concomitant medications were not reported.This report concerns 1 patient and 2 devices.On an unknown date, the patient was started on vacuum-induced hemorrhage control system (jada system #1) (lot#: and expiry date were not reported) for unknown indication (product used for unknown indication).It was told by the nurse stated that it was clogged up with clots (device occlusion) and another physician came in to place the second vacuum-induced hemorrhage control system (jada system # 2) (lot# and expiry date were not reported) for unknown indication (product used for unknown indication).The patient did well with the second vacuum-induced hemorrhage control system (jada system # 2) in place (required intervention).The nurse also stated the physician said the patient was dilated 3 centimeters (cm) but she did not think the patient was dilated 3cm (wrong technique in device usage process).The nurse also said the event was not "an adverse event" but "more like user error".The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the event of "device occlusion" was determined to be serious: required intervention.Medical device reporting criteria: serious injury.(b)(4).
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