Jiangsu impaired eye surgery for patients after 26 issues medical device problem | |-medical disputes _ news
Original title: 26 patients with eye diseases in affiliated hospital of Nantong University of eye damage after officials say deeply saddened
CNS, Nanjing, April 9 (reporter Cui Jiaming)-a few days ago, Nantong 26 ophthalmopathy patients report that they injected in Nantong University Hospital called perfluorocarbon gas, used in the treatment of conditions such as retinal detachment, but the batch of medical gas belonging to medical devices, after the State food and Drug Administration recalled. At present, the two patients have been blind.
On April 9, the affiliated hospital of Nantong University release reported that this event uses Jing ming, Tianjin new technology development co, Ltd (hereinafter referred to as Jing ming, Tianjin) produces eye use perfluoropropane gas caused, apart from the timely redress for victims and follow up review, and take the company to court.
Informed the show Crystal clearly stated the same batch used Tianjin eye use perfluoropropane gas in patients with adverse reactions after a total of 26 officers, took place on June 5, 2015 until June 29. Symptoms of adverse reactions are intraocular fibrinous exudation and lens opacity, atrophy of the optic nerve, retinal vascular occlusion etc. According to the expert opinion of 23 patients with partial overnight salvage operation, remove residual problems gas, fill silicone oil and continued close follow-up and treatment.
Meanwhile, affiliated hospital of Nantong University in communications, said unfortunately for the patients suffering deeply saddened, active remediation and tracking patient review.
Today, Nantong city, food and Drug Administration also said this event to notify, will closely watch developments, inform the relevant case information will be the first time.
Nantong food drug supervision authority informed said, July 4, 2015 late, Nantong food drug regulatory Council received Nantong University subsidiary hospital 7 copies bad event report, are involved same products "eye with full fluoride propane gas" (marked production manufacturers: Tianjin Crystal Ming technology development limited, registered account: country food drug prison armed (associate) Word 2014 No. 3221571,, products standard: YZB/country 4936-2014 eye with full fluoride propane gas, batch: 15040001, Specification: 15ml) in Uveitis patients after reaction may result in permanent damage to body structure, the hospital had to stop using the product and organization to carry out the corresponding treatment.
After receiving the report, Nantong city, food and Drug Administration study on disposal and the use of products in the city at once urgent investigations, sync report to the Center for adverse drug reaction monitoring in Jiangsu Province. The next day, the composition of the Bureau of investigation team went to the hospital to carry out on-site investigations, product qualification, product approval, purchasing procedures, inspection reports, and storage procedures, sales materials such as powers of Attorney conducted a comprehensive investigation, sampling on all of the batch product inventory control, sent to China's food and drug inspection Institute testing.
On July 6, 2015, the Bureau issued a moratorium on the use of the city Crystal ming, Tianjin new technology development company production of "ophthalmic perfluoropropane gas" issued an emergency notice, calling for the immediate suspension of Jing ming, Tianjin new technology development produced by the company "eye with perfluoropropane gas" products. National Office issued a moratorium on the sale to the nation after using Jing ming, Tianjin new technology development produced by the company issued the notice on ophthalmic perfluoropropane gas, called for an immediate stop to use the product.
Communications also said that on September 1, 2015, the food and Drug Administration to Nantong, Nantong city inspection report and investigation service of University Hospital, hospital provides manufacturers, product qualification of materials, final inspection report, warehousing, sales of power of Attorney and other material evidence. Since this fails to dispose of medical disputes from the end, the Council will keep a close watch on the progress, inform the relevant case information will be the first time. (End)
Responsible editor: Kun Qu SN117
Article keywords:Issues medical devices medical disputes
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江苏26名患者术后眼球受损 手术用问题医疗器械|问题医疗器械|医疗纠纷_新闻资讯
原标题：南通大学附属医院26名眼疾患者术后眼球受损 官方称深感痛心
中新网南京4月9日电 (记者 崔佳明)日前，南通26名眼病患者反映，他们在南通大学附属医院注射了一种名为全氟丙烷的气体，用来治疗视网膜脱落等病症，可谁知该批次医用气体属于问题医疗器械，后被国家食药监总局召回。目前，已有两名患者失明。
4月9日，南通大学附属医院发布通报称，这起事件系使用天津晶明新技术开发有限公司(下称天津晶明)生产的眼用全氟丙烷气体引发，除对受害者采取及时补救与追踪复查外，已将该公司诉至法院。
通报显示，使用天津晶明生产同一批次的眼用全氟丙烷气体后出现不良反应的患者共有26名，均发生在2015年6月5日至6月29日。不良反应的症状主要表现为眼内纤维素性渗出、晶状体混浊、视神经萎缩、视网膜血管阻塞等。根据专家意见对其中的23名患者分批分次连夜进行了补救手术，清除残余问题气体，填充硅油等，并持续进行密切随访和治疗。
同时，南通大学附属医院在通报中表示，对于患者遭遇的不幸深感痛心，积极补救和追踪病人复查。
今天，南通市食品药品监督管理局也对此事件对外通报称，将密切关注事态进展，相关案件信息将在第一时间通报。
南通市食品药品监督管理局通报说，2015年7月4日晚，南通市食品药品监管局接到南通大学附属医院7份不良事件报告，均涉及同一产品“眼用全氟丙烷气体”(标示生产厂家：天津晶明新技术开发有限公司，注册账号：国食药监械(准)字2014第3221571号，产品标准：YZB/国4936-2014《眼用全氟丙烷气体》，批号：15040001，规格：15ml)，在使用后病人发生葡萄膜炎反应，可能导致机体功能结构永久性损伤，院方已停止使用该产品并组织开展相应救治。
接到报告后，南通市食品药品监督管理局当即研究处置工作并对全市产品使用情况紧急调查，同步向江苏省药品不良反应监测中心报告。次日，该局组成调查组赴医院开展现场调查，对产品生产企业资质、产品批文、购进手续、产品出厂检验报告、出入库手续、业务员的授权书等材料等进行了全面调查，对该批次产品库存全部抽样控制，派专人送中国食品药品检定研究院检测。
2015年7月6日，该局向全市发出《关于暂停使用天津晶明新技术开发有限公司生产的“眼用全氟丙烷气体”的紧急通知》，要求立即暂停使用天津晶明新技术开发有限公司生产的“眼用全氟丙烷气体”产品。后国家总局向全国发出《关于暂停销售使用天津晶明新技术开发有限公司生产的眼用全氟丙烷气体的通知》，要求立即停用该批产品。
通报中还称，2015年9月1日，南通市食品药品监督管理局到南通大学附属医院送达检验报告并立案调查，对院方提供的生产厂家、产品的资质材料、出厂检验报告书、出入库单、业务员的授权书等材料进行了证据固定。由于该起医疗纠纷未处置终结，该局将密切关注事态进展，相关案件信息将在第一时间通报。(完)
责任编辑：瞿崑 SN117
文章关键词： 问题医疗器械 医疗纠纷
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