On 8/17/2011, an oral dose of 100.2 mCi of NaI-131 (
sodium iodide) was administered to a female patient of childbearing age for radioablation of papillary thyroid carcinoma post thyroidectomy. The patient became pregnant approximately a week after dose administration, despite proper pre-therapy orientation and against medical advice. This was brought to [the licensee's] attention by the patient's OB/GYN physician on 9/28/2011. On that same date, the patient was contacted via telephone and was alerted and oriented as to the possibility of harmful effects of radiation to the embryo. On 10/4/2011, that same orientation was performed more thoroughly in person. Full dosimetric analysis was performed by [the licensee's] medical physicist on 10/5/2011. A complete medical report, including possible effects and complications was given to the patient and referring OB/GYN physician on 10/19/11. The list of possible complications included: Miscarriage, neurologic system damage, intrauterine growth retardation, mental retardation, and increased risk of development of cancer.
To prevent recurrence of this incident, [the licensee has] created a barrier system, where the department secretary and then the nuclear technologist verifies the patient's paperwork before the physician. We have also revised our patient instructions for childbearing age patients.
The licensee has verbally discussed this incident with R2 (Bermudez).