ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는
Serbia
에서 Cochlear Limited 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
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.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
데이터 추가 비고
원인
Since a recent increase in the number of nucleus ci512 implant failures was identified, and for precautionary reasons, the manufacturer decided to withdraw these implants from the market until it determined the causes of the problem. in case of implant failure, the recipients can be re-implanted with nucleus freedom series implants. an external device of the series 5, or any series of this manufacturer, is not subject to adverse drug reactions, nor is it subject to market recall.