안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
데이터 추가 비고
The company states that in 2010 its supplier changed the formulation of lubricating oil without informing them. Such changes can cause multiple cracks after 6-12 months, some manifolds have performed well so far. This problem only happened in the manifold manufactured in 2010, since the beginning of 2011 has been changed to another type of lubricating oil. Anvisa is following this action.
원인
Product has small cracks in its extension.
조치
To users, immediately stop the use of the affected product, check the batches of the affected product in its stock and segregate, contact the manufacturer to arrange the collection.