A few days ago, 26 eye patients in Nantong, Jiangsu Province, reported that they injected a gas called perfluoropropane in the hospital of Nantong University to treat diseases such as retinal detachment. Who knows that the batch of medical gas belongs to the problem medical device, The State Food and Drug Administration recalled. Currently, two patients have been blind. Yesterday, the Nantong University Affiliated Hospital issued a notice saying that the incident was triggered by the use of perifluoropropane gas produced by Tianjin Jingming New Technology Development Co., Ltd., except for timely remediation and follow-up review of the victims. To the court.
The report showed that 26 patients with adverse reactions after the same batch of ophthalmic perfluoropropane gas were produced by Tianjin Jingming, both occurred from June 5 to June 29, 2015. Symptoms of adverse reactions mainly include intraocular cellulose exudation, lens opacity, optic atrophy, and retinal vascular occlusion. According to the expert opinion, 23 of the patients underwent remedial surgery in batches, cleared residual gas, filled with silicone oil, etc., and continued close follow-up and treatment.
At the same time, the Nantong University Affiliated Hospital said in the report that it is deeply saddened by the misfortune of the patients, and actively remedies and tracks the patient's review.
Yesterday, the Nantong Food and Drug Administration also reported that it will pay close attention to the progress of the situation, and the relevant case information will be notified at the first time.
The Nantong Food and Drug Administration reported that on the evening of July 4, 2015, the bureau received 7 reports of adverse events from the Nantong University Affiliated Hospital, all involving the same product “perfluoropropane gas for eye useâ€. Membrane reaction may cause permanent damage to the functional structure of the body, and the hospital has stopped using the product and organized the corresponding treatment. The bureau immediately studied the disposal work and conducted an emergency investigation on the use of the city's products, and reported to the Jiangsu Provincial Adverse Drug Reaction Monitoring Center. On the next day, the bureau formed an investigation team to conduct on-the-spot investigations, and conducted a comprehensive investigation on the qualifications of product manufacturing enterprises, product approvals, purchase procedures, product inspection reports, procedures for entering and leaving the warehouse, and authorization letters for salesmen. The batch of product inventory is all sampled and controlled, and sent to the China Food and Drug Administration Research Institute for testing.
On July 6, 2015, the bureau issued an urgent notice to the city requesting the immediate suspension of the use of “optical perfluoropropane gas†products produced by Tianjin Jingming. After the State Food and Drug Administration issued the "Notice on Suspension of Sales of Ophthalmic Perfluoropropane Gas Produced by Tianjin Jingming New Technology Development Co., Ltd." to the country, it was requested to immediately deactivate the batch of products.
According to the report, on September 1, 2015, Nantong Food and Drug Administration sent an inspection report to the Nantong University Affiliated Hospital and filed an investigation. Since the medical dispute has not been disposed of, the bureau will pay close attention to the progress of the situation, and the relevant case information will be notified at the first time.
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