Actifuse ABX 1-2mm, manufacturer Apatech, models 506005078047 (2,5mm); 506005078048 (5.0mm) and 506005078049 (10.0mm). Record 80253610018. Series Affected: See Annex. 의 안전성 경고
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
According to the company, in surgical procedures in which the device contacts the cerebrospinal fluid through a hard opening (iatrogenic injury), the use of a medical device that has increased endotoxin levels may increase the typical inflammatory reaction for surgery and contribute to adverse health consequences. There are no reports of adverse events.
원인
Product with endotoxin level test result above the specified limits, for a stability batch.
조치
The company that holds the registration will collect and destroy products with an expiration date before 07/29/2017. Product distributors are advised to identify and segregate the product for later collection by the company.