National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는
Colombia
에서 Smith & Nephew Inc. 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.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
데이터 추가 비고
원인
The manufacturer states that he has made changes in the instructions for use and in some canister the entrance port may be deformed, leading to the fact that his unknowing may cause possible adverse events to occur on the patients.
RENASYS EZ, RENASYS EZ PLUS, RENASYS EZ MAX, RENASYS GO, specific lots
제품 설명
This device is indicated in patients who may benefit from a suction device (negative pressure) to promote wound healing eliminating fluids (including body and irrigation fluids, wound exudates and infectious materials.) Includes acute, traumatic, sub acute wounds. and by dehiscence, ulcers (such as pressure or diabetics), partial thickness burns, flaps and grafts.