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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 409038 July 2004 07:00:0010 CFR 35.3047(a)Medical Event Involving Unintended Dose to Embryo/FetusA female patient undergoing treatment for Graves disease received 26.6 millicuries I-131. The patient received counseling and a pregnancy test on 7/8/04 (negative results) prior to treatment. Subsequent to treatment the Hospital was informed by her husband that a home pregnancy test showed positive. The Hospital contacted the patient and scheduled a second pregnancy test on 7/23/04. The test results confirmed the pregnancy on 7/24/04. The prescribing physician has been informed. The preliminary assessment performed by the Hospital concluded that this medical event would most likely result in either a spontaneous abortion or have no impact on fetus development, i.e., at this stage in the pregnancy (zygote) the thyroid has not developed.