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.
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Medical Device Safety Alert
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Medical device safety alert: ormco zoo master pack 2e 3/16 hvy kangaroo
medical device manufacturer, ormco corporation has issued a medical device safety alert concerning zoo master pack 2e 3/16 hvy kangaroo [part no.: 630-0040; lot no.: 061277866].
boxes of zoo pack elastics labeled to contain packages of kangaroo elastics may contain packages of kangaroo and impala elastics. there are no safety or efficacy issues associated with this product. product recall and replacement is ongoing.
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 12 october 2012.