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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 5439514 November 2019 05:00:00Agreement StateTennessee Agreement State Report - Medical Event That Resulted in Skin InjuryThe following information was received from the state of Tennessee via email: Patient treated with Lutathera (Lu-177 dotatate) on November 14, 2019. It was determined during her infusion that the Foley catheter was leaking. After the leak was identified, proper decontamination procedures were performed. The patient was instructed upon discharge that there was a chance for potential skin injury. Licensee reported that the estimated skin dose was 7 Gray (Gy). On November 18, 2019, the patient informed her provider that there was skin irritation in the peri-gluteal and peri-labia areas. It was determined that this was skin injury consistent with radiation injury. A follow-up report will be submitted upon receipt of a written report from the licensee. Tennessee Event Report ID No.: TN-19-161 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4885629 January 2013 04:00:00Agreement StateAgreement State Report - Catheter Leakage During TreatmentThe Division of Radiological Health was notified on Tuesday March 26, 2013, by a representative from Vanderbilt (University), of a misadministration. A patient was treated January 29, 2013, with Iodine 131-MIBG (metaiodobenzylguanidine). The patient stayed in the hospital for 4 days until February 2, 2013. Foley catheter leakage occurred during this interval, but not recognized as a misadministration because there was no visible effect. The patient returned for a second treatment on March 19, 2013, at that time a rash was noted and attributed to the catheter leakage during the initial treatment in January. Inspectors from the Nashville Field Office will (request additional information and) follow-up and keep NRC informed of the status of our investigation. Tennessee Division of Radiological Health Report Number: TN-13-044 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.