patient was bleeding heavily from the nose and appeared to have soiled himself and aspirated on his vomit Tag

MAUDE Reports are Fraud Reports: FDA & Johnson & Johnson’s Acclarent Relieva Spin Sinuplasty System

February 18, 2016 ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results Model Number N/A Device Problem No Known Device Problem Event Date 12/12/2015 Event Type  Injury Event Description Acclarent was informed of an event on (b)(6) 2016, which occurred on (b)(6) 2015, during a balloon sinuplasty in-office (bspio)...