Department of Health에 따르면, 해당 안전성 경고 는
Hong Kong
에서 Oscor 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.
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 safety alert: oscor bipolar temporary myocardial heartwire
the health canada has posted a medical device safety alert concerning bipolar temporary myocardial heartwire (model no.: tme 64-s; lot/serial no.: c1-07056) manufactured by oscor inc.
according to the health canada, spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). the defect affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised.
for details, please refer to the health canada website:
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/
_list/rec-ret_md-im_date_oct-dec_2012-eng.Php
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 28 november 2012.