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
A customer complaint triggered a technical investigation which confirmed that specific lots of t3462 broth, could produce out of specification high quality control results for the antibiotic tigecycline with the quality control organism enterococcus faecalis. further investigations identified that a different style of cap was used during the manufacture of a number of lots which could affect the seal on the vial and potentially result in oxygenation of the broth. the cap was also used for defined lots of cp11410 and cp112-10. therefore, all products that used the same cap and that could be used in conjunction with tigecycline, are being recalled. .