Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 Geon Corporation 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.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
데이터 추가 비고
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
원인
Several incidents were reported to infarmed due to failure of the performance of the aforementioned device, namely the presentation of incorrect readings of body temperature (for example, a reading of 37ºc when the actual temperature would be around 40ºc). consequently, the manufacturer of that device, geon corporation, was contacted to investigate the situation. the conclusions of the report submitted were contradictory since, in the same case, the problem was attributed in turn to a defect in the assembly of the device during manufacture and poor handling when it was transported by air to portugal (the manufacturer is headquartered in taiwan, roc).
조치
In view of the above, and considering INFARMED that the manufacturer would not be able at this stage to ensure the correct functioning of these devices and in order to protect the health of potential users of them, it was decided to suspend the commercialization of digital thermometers GEON in the national territory of Portugal.