Adverse Events
nosebleed
ADVERSE EVENTS, EVENTS, EVENT, NOSEBLEED
A total of 111 participants (30.2%) experienced disease-related expected adverse events, including 67 (36.4%) in the minimal suction group and 44 (24.0%) in the enhanced suction group. The most common event was hospitalization after ED discharge (18 of 367 patients [4.9%]: 11 of 184 [6.0%] in the minimal suction group and 7 of 183 [3.8%] in the enhanced suction group).Unexpected adverse events occurred in 2 infants in each group who had a nosebleed leading to a medical visit. Neither infant required any intervention, and both events were judged as possibly device-related but mild. Five infants were admitted to intensive care unit (2 in the minimal suction group and 3 in the enhanced suction group); all recovered and none of the events was judged as being device related.