Department of Health에 따르면, 해당 안전성 경고 는
Hong Kong
에서 Coloplast 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.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
데이터 추가 비고
Medical Device Safety Alert
원인
Medical device recall: coloplast catheter valve
medical device manufacturer, coloplast, is initiating a medical device recall regarding three lots (2769329, 2799062 and 2823831) of catheter valve (item number: 380851).
a sterility test on coloplast catheter valve has failed, which raises concerns over the sterility of the catheter valves. coloplast has not received any complaint on the catheter valve related to this issue and therefore no signals for safety concerns. it is assumed that the catheter valve is used in a non-sterile environment. under this assumption the lack of sterility is very unlike to affect the patient and user’s safety.
coloplast is notifying the affected customers.
according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.