Events

TEXTILE AND POLYURETHANE SILICONE MAMMARY IMPLANTS 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Silimed - Silicone e Instrumental Médico e Cirúrgico e Hospitalar Ltda. 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
    768
  • 날짜
    2003-12-01
  • 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
    It is of fundamental importance that healthcare professionals are aware of all the information advocated by the manufacturer, especially the instructions for use and possible side effects that may arise from the use of such products. If there is a need to notify any adverse event or quality deviation on this or any other health products (medical articles, orthoses and prosthetics, medical equipment and in-vitro diagnostic kits), please contact: ANVISA - AGENCY NATIONAL SANITARY SURVEILLANCE Unit of Technovigilância - UTVIG SEPN 515 - Block B - 4th. Andar - Sala 01 - Asa Norte - Brasília - DF CEP: 70.770-502 Tel .: (0xx61) 448 1331/448 1485 Fax .: (0xx61) 448 1257, e-mail: tecnovigilancia@anvisa.gov.br It is convenient , the Avulsa Technovigilance Notification form can be used on the website: http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp
  • 원인
    Anvisa informs that it received, through its unit of technovigilance - utvig / ggtps, notifications that report the occurrence of adverse events possibly related to the use of silicone mammary implants. the reported events report that, after bacteriological analysis, the presence of mycobacterium fortuitum was detected. among the identified symptoms, according to the reports, the afebrile state and the late dehiscence accompanied by intermittent serous secretion can be mentioned. the phlogistic signs usually begin on the 20th postoperative day, with seroma formation (sometimes with spontaneous drainage). bacterioscopy and culture may be negative by the usual exams, therefore, they should be specifically requested for baar bacilli.
  • 조치
    The UTVIG / GGTPS continues to investigate the notifications received from the product, and to date, nothing can be concluded regarding the probable or probable causes of the occurrence of the notified events. Conceptually and according to the international literature, it is worth remembering that the occurrence of adverse events with health products can possibly be attributed to misconceptions about the procedures performed (handling, asepsis, sterilization, use of meters, etc.). In practice, any deviations in the indication, use, etc. can collaborate for the occurrence of such events, as previously reported.

Device

TEXTILE AND POLYURETHANE SILICONE MAMMARY IMPLANTS

Manufacturer

Silimed - Silicone e Instrumental Médico e Cirúrgico e Hospitalar Ltda.
  • Source
    ANVSANVISA