Events

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380. Lots: See attachment 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 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
    1292
  • 날짜
    2013-09-04
  • 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
    The company reports so far, there have been no reports of injury or adverse events in patients as a result of this defect. However, an interruption in the flow of irrigation fluid has the potential to cause overheating of the ablation tip and formation of a burn or thrombus, which in turn may present a thromboembolic risk to the patient./////24/11 / 2014 - The company announced the closure of this field action. According to the company all the customers were contacted, being collected 145 units of the product.
  • 원인
    The company that owns the record reports that biosense webster, maker of the product, recently noticed an increase in reports of interruption of irrigation flow. an internal investigation has identified a defect in the production process, which may cause occlusion of the irrigation lumen.
  • 조치
    The company requests that the "Problem description" section be read carefully in the letter attached to this alert. - Immediately identify and separate all affected products to ensure that the product is not used. Keep a copy of this letter along with the THERMOCOOL SMARTTOUCH® catheter until all units are returned to Biosense Webster. - Sign and return the attached Voluntary Field Withdrawal Form, according to the instructions on the form. - Coordinate the return of all THERMOCOOL SMARTTOUCH® catheter units that may be in your inventory, according to the instructions on the Voluntary Field Withdrawal Certification Form. - Transmit this notification to everyone in your facility who needs to be informed. -Be careful of this notification until all affected products have been returned to Biosense Webster. - If any of the affected THERMOCOOL SMARTTOUCH® catheters have been sent to another facility, contact the facility to arrange for a return.

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