Product name: Mucosal Atomization Device Technical Name: Devices ANVISA Registration Number: 80117580370 Hazard Class: I Affected Model: MADgic LMA (MAD720) Serial numbers affected: MAD720 Lot: 160404 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA; Teleflex Medical 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
    2129
  • 날짜
    2016-12-19
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    1. If there are products in stock, immediately discontinue use of the product and segregate them in the quarantine and request recall. 2.To return the product, complete the recall recall form and send it to the distributor or via email recalls @ teleflex. with. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the recall form, forward it to the distributor or via e-mail to recalls@teleflex.com. This will confirm that you have received this collection notice.
  • 원인
    The manufacturer teleflex has sent a statement regarding safety issues regarding investigations carried out in other countries containing product / lot sent to brazil. as part of the release, the recall of these products becomes necessary, once after investigation it has been concluded that the affected products can produce a continuous flow of medication, instead of a medication atomizer. serious health consequences are unlikely to occur in the event of failure, but this may result in inadequate topical anesthesia which may lead to discomfort, further attempts to administer topical anesthesia, or the use of alternative anesthesia methods.
  • 조치
    Field Action Code RAM 15/2016 triggered under the responsibility of the company EMERGO BRAZIL IMPORT IMPORTATION AND DISTRIBUTION OF MEDICAL PRODUCTS HOSPITALARES LTDA. Company will make collection for later return to the manufacturer.