Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 Baxter Hospitalar Ltda. 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
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
Baxter Hospitalar Ltda reports that: "Previous reports of a similar nature have been associated with the use of dialysers with unmodified cellulose acetate fiber. It is not known to what extent the time and / or storage conditions of the dialysers influence this type of incident. In Brazil we have not received any reports of Red-Eye Syndrome using these dialysers. "///// If your EAS received the batch in question, immediately suspend the use and contact the Manufacturer or your local representative. The Tecnovigilância / ANVISA Unit will be monitoring all actions carried out by the company.
원인
Reports received from a dialysis clinic in mexico, where 10 patients reported adverse events including conjunctivitis, iritis, malaise, myalgia, and arthralgia combined. these events are related to the syndrome known as "red eye syndrome".
조치
BRAZIL - 11.11.2003 - Baxter Hospitalar Ltda is initiating the voluntary withdrawal of the A01C04 lot from the dialyzer CA 210 by means of a letter dated 11.11.2003.