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.
Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
데이터 추가 비고
원인
- no sanitary registry or imports of the product were found, according to the research carried out by the dnm.
- include within the list of falfra.
조치
- Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment.
- Perform searches of the product in the BPAs or routine searches.
- To find the product in existence within the country, a national alert will be issued.