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Abstract #1119

A 10-year Review of MRI-Related FDA Adverse Event Reports

Jana G Delfino1, Daniel M Krainak1, Stephanie A Flesher1, and Donald L Miller1
1US Food and Drug Administration, Silver Spring, MD, United States

We provide a breakdown of the adverse event reports received by FDA during a 10-year period (2008-2017). Reports were manually categorized into eight mutually-exclusive event types. Thermal events were further sub-categorized by probable root cause. Objects that became projectiles were sub-categorized. Adverse events related to MR systems consistent with the known hazards of the MR environment continue to be reported to FDA. Thermal events were the most commonly reported serious injury (59% of analyzed reports). Mechanical events (11%), projectile events (9%), image quality issues (6%), and acoustic events (6%) were also observed.

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