Events

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC. 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
    1467
  • 날짜
    2014-11-24
  • 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
    Based on the research, including the medical evaluation of the health risk profile of the post-marketing reports, Biosense Webster believes that the general risk profile of these catheters is still within acceptable limits when used in the indicated population. To date, no harm or adverse events have been reported in patients as a result of this type of occurrence. The manufacturer would like to stress that there is no flaw or deterioration in the characteristics associated with these products. Therefore, the product may continue to be used.
  • 원인
    The registrant reports that biosense webster, a division of johnson & johnson medical nv / sa, has observed 34 complaints with a frequency of 0.03% related to bending / breaking in different locations on the stem (body) of the thermocool smarttouch catheter, during the period from january 2012 to july 2014. none of these reported claims were associated with adverse events. through the investigation, manual pre-casting of the distal catheter shaft and the use of 8 fr sheaths have been identified as the two primary causes for these events, and may be related to the process of using the products. additional note: this is a voluntary communication from the manufacturer to the customers regarding the event reported through customer complaints. the information contained in this field safety notification is not related to defect or any other defect of the products mentioned.
  • 조치
    The company requests that the information contained in the Customer Letter (Security Notification) be carefully read; • Pass this notice to anyone involved in your organization who needs to be informed, including the clinical staff who use the THERMOCOOL SMARTTOUCH catheters and who sign the receipt form; • Review, complete, sign and return the receipt form according to the instructions listed on the form; • Keep a copy of this letter with the product. For more information, please check the Customer Letter - Annex I

Device

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smartt...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC.