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Not graded by the source13 Nov 2018FDA MAUDEAuris HealthMonarch Platform3014447948-2018-00002Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHYSICIAN REPORTED A PNEUMOTHORAX 2 HOURS POST PROCEDURE AND REQUIRED CHEST TUBE PLACEMENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND RELEASED UPON THE PNEUMOTHORAX RESOLVING ITSELF WITH NO RESIDUAL EFFECTS.
cause not established3014447948-2018-00002Auris HealthMonarch PlatformRead the record ↗Not graded by the source25 Jul 2018FDA MAUDEAuris HealthMonarch Platform3014447948-2018-00001Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A POST PROCEDURE X-RAY INDICATED A 10% PNEUMOTHORAX. A CHEST TUBE WAS USED AND THE PATIENT WAS ADMITTED FOR OBSERVATION OVERNIGHT. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT INCIDENT.
cause not established3014447948-2018-00001Auris HealthMonarch PlatformRead the record ↗