현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
데이터 추가 비고
원인
Through complaints, angiomed has identified products with the combinations of markings and batch numbers listed in annex 1 that may contain a mandrene cap at risk of breakage. if the mandrene cap broke, the user had to remove the needle and re-insert the new needle to complete the biopsy, or abandon the biopsy completely due to certain unforeseen circumstances.
our records show that your establishment has purchased one or more units of affected products with combinations of labels and batch numbers. all other products with combinations of markings and batch numbers not listed in the safety corrective action notice may continue to be used at your establishment because they are safe to use and are not subject to this product recall.