不良事件是指医疗器械使用过程中可能导致死亡、重大伤害、功能失常、不良反应等的事件。制造商需要及时向FDA报告与其医疗器械相关的不良事件,以便FDA监测和评估医疗器械的安全性和有效性。 医疗器械召回(Medical Device Recall):如果存在医疗器械可能存在缺陷、不安全或不符合法规要求的情况,制造商可能会主动发起召回行动。...
Medical device therapeutic failures Consumers who wish to report an adverse event to FDA can do so using the online reporting form insteading of expecting the healthcare provider to report to FDA. The report will include personal information about the consumer, product details, problem or reaction...
Under the Medical Device Reporting (MDR) regulation, there is a mechanism that allows FDA and device manufacturers to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions of devices to detect and correct problems in a timely manner. All manufacturers of legally...
are encouraged to report to manufacturers and national competent authorities.2 With greater than 70 000 adverse event reports submitted every month, the MAUDE database currently represents the FDA's primary source of safety signals triggering medical device safety communications, and has the capacity to...
Cert of GUDID Reporting FDA now requires medical device manufacturers and importers to submit adverse event reports in electronic format. Device manufacturers and importers are required to submit adverse event reports to FDA when evidence suggests a device may have contributed to a patient death or se...
municipal or local government or whether it is accredited by a recognized accreditation organization.(If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.如果不良事件符合报告标准...
In a series of cases from 2000 to 2002, involving a medical device(an ultrasound gel), intrinsic contamination by BCC led to serious bloodinfections after the gel was used in association with transrectal prostatebiopsies (Ref. 6).这些微生物是机会性人类病原体,可导致严重的致命感染(参考文献 2、...
从2018年初公布“医疗器械安全计划(Medical Device Safety Action Plan)”;11月,改革510(k)计划;12月4号,更新De Novo审查计划;12月14号又也推出了全新的安全技术计划(STeP);今年1月23号推出510(k)最终指南征集方案。 哪怕在政府关门期间,也没有放弃,而这些政策都只有一个指向,那就是医疗器械的安全问题。这些...
The US Food and Drug Administration (FDA) is alerting clinicians about an increasing number of medical device reports (MDRs) associated with the use of surgical staplers for internal use and implantable surgical staples and providing additional recommendations to help reduce risks associated with their...
adverse event files. If you are a manufacturer, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device ...