Trade name: HEMOSTOP. Technical Name: Gingival Retractors and Hemostatic. ANVISA registration number: 10186370148. Risk class: II - Medium Risk. Affected batches: 1938021, 1938031, and 1962491 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Dentsply Indústria e Comércio 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
    2041
  • 날짜
    2016-08-30
  • 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
    If the customer receives the wrong barcode product, he must inform Dentsply that the barcode product will be made. The following actions will be taken: - Rework of the customer tags that have bought more than 50 units of Hemostop with the wrong barcode. This rework will be done by our business advisor. - Send a letter of communication of data to customers who buy less than 50 units to verify if they need some rework units. If there are affected customers, the labels will be replaced in dental by our business advisor. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • 원인
    The product hemostop, presented error in the labeling with the barcode changed. the exchange of the bar code of the product in question does not pose a risk to the population and does not give the product characteristics that are harmful to health. based on the description of the problem. it was concluded that the error can not cause health problems. however, some actions will be taken to minimize the error in the market without the need to withdraw the product on the market.
  • 조치
    Field Action Code 3 triggered under the responsibility of the company Dentsply Indústria e Comércio Ltda. Company made correction in the field for exchange of labeling. Action Completed.

Manufacturer