CI nets 6-item 483 for failure to report AEs; informed consent, record maintenance also noted.(Clinical investigators)

Hyun Kim, M.D., Johns Hopkins Hospital, Baltimore, Baltimore District

Hyun Kim, M.D., John Hopkins Hospital, Baltimore, was cited in a comprehensive Center for Devices inspection for not submitting two unanticipated adverse events (AEs) to the IRB, failing to obtain informed consent and neglecting to maintain records of subjects' condition.

The audit was conducted by Stephanie Shapley and Anastasia Piliafas-Brown of the Baltimore District Office.

The EIR noted that Kim is an interventional radiologist and the two medical devices studies he conducted were titled "Pivotal Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids," and "Pivotal Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids, Long Term Follow-Up …