Events

Cardiac Monitoring Electrode - Model 2223BR. Anvisa Registry: 80284930186. Lots affected in Brazil: 0818200376; 0818400251; 0820700723; 0820900183; 0821000474; 0821100554; 0821200380. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 3M do Brasil 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
    944
  • 날짜
    2008-10-19
  • 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
    According to 3M do Brasil Ltda, the level of risk associated with the event is considered low, since the occurrence is low (occasional) and the probability of serious adverse health consequences is practically non-existent - due to the easy identification by the professional who is using the product, to notice any change in the monitoring signal. The problem was caused by a deviation in the production equipment and occurred in the periods of 01 to 03/07/2008 and 28 to 31/07/2008. According to the Regulatory Affairs Department of 3M do Brasil Ltda, the company has not yet received reports of related adverse events. The forecast for completion of the collection is 3 months.
  • 원인
    The product registration holder (3m do brasil ltda.) has verified that, on some electrodes of the lots mentioned, the pin and cotter pin insertion can be easily released.
  • 조치
    According to information submitted to the Anvisa Technological Monitoring Unit (UTVIG / ANVISA), to date the actions of the registry holder to solve the problem were as follows: (1) Implementation of in-process tests and quality control to assess the fit of the pins and contrapinos with determined frequencies and to each adjustment of machine (action already implemented); (2) Risk Analysis of the problem, with the objective of evaluating the impact on the client's health, product quality; (3) Identification of customers who purchased the lots in question; (4) Notice on the payment to customers who purchased the lots in question; (5) Contact with Technovigilance to publicize voluntary collection. To the users and distributors of the products mentioned in this alert, the following actions are recommended: (1) To segregate in its establishment any remaining amount of product of the batches in question; (2) Identify the products at risk found, so that there is no inadvertent use; (3M do Brasil Ltda. / Rodovia Anhanguera, Km 110, Sumaré - SP / Contact: Érika Silva (esilva@mmm.com) / Cristiane Franco (2) Please contact 3M to let us know if you have purchased one of the lots (registries3m@mmm.com) Tel .: 0800-153131).

Device

Cardiac Monitoring Electrode - Model 2223BR. Anvisa Registry: 80284930186. Lots affected in Brazi...

Manufacturer

3M do Brasil Ltda.