Events

COCHLEAR IMPLANT. . Cochlear implants are medical devices that convert sound signals into electrical signals, which allow direct stimulation of the auditory nerve fibers through an electrode implanted in the cochlea. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 N/A 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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    664
  • 날짜
    2002-08-01
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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
    Following these events, one of the cochlear implant manufacturers of ADVANCED BIONICS CORPORATION voluntarily suspended the commercialization of the AB-5100 H11 (Hifocus I electrode) and AB-5100 H12 (HiFocus II electrode) of the CLARION brand. BRAZIL - August 23, 2002 - The National Agency of Sanitary Surveillance / ANVISA, has detected the existence of a similar product registered in Brazil and is investigating if there is any relation of this with the aforementioned product.
  • 원인
    The national institute of pharmacy and medicines (infarmed) was aware of the occurrence of 25 reports worldwide (with a higher incidence in europe) of bacterial meningitis potentially associated with the use of this product.
  • 조치
    In order to safeguard Public Health and to prevent the occurrence of bacterial meningitis in individuals with cochlear implants, INFARMED recommends that: "Centers responsible for implanting this type should inform individuals with cochlear implants (or their parents, in the case of of the main signs and symptoms of meningitis and that the same individuals are urged that if they detect the presence of the same signs or symptoms, urgently contact their attending physician and also that the history of vaccination for pneumococci and Haemophilus influenzae serotype B and that, if it has not been done, the hypothesis of vaccination of the individuals with cochlear implants, as well as the candidates to carry out this type of intervention be considered "

Device

COCHLEAR IMPLANT. . Cochlear implants are medical devices that convert sound signals into electri...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA