Events

Product name: Disposable Stylus Technical Name: Biscuit ANVISA Registration Number: 10229650002 Hazard Class: II Model Affected: Number 11 Serial Numbers Affected: Lot: EEC2756 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Cirúrgica Brasil Comercial e Importadora Ltda.; Cirúrgica Brasil Comercial e Importadora 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
    2268
  • 날짜
    2017-04-12
  • 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
    Identify, by visual inspection, the presence of stains and / or oxidation of the material. The material should not be stored in a humid place or have its packaging wet.
  • 원인
    We were notified on 03/22/2017 via e-mail by covisa (health surveillance coordination) of the municipality of são paulo, to attend on march 2, 2017 a technical expertise at the adolfo lutz institute, in two units collected by the inspectors in the product: disposable stylus no. 11 - batch: eec2756, in which we monitored and observed that the two sealed units presented oxidation in the slide, so far we have not received the report of the analysis. however, after that, we have adopted a voluntary recall in which we send an e-mail and registered letter with ar (acknowledgment of receipt). notes: the 4,900 units produced were sold to a single location, the municipal health fund (sp). we have not received any units so far. the alert is an effective way to reach all health units in the municipality of são paulo (hospitals, ubs, etc.), which may possibly have units of the lot in question. on 03/24/2017, the interim injunction of the lot: eec2756 by suvis / covisa was published in the official gazette of the municipality (official gazette of the city of são paulo).
  • 조치
    Field Action Code 3003/17 triggered under the responsibility of the company Cirúrgica Brasil Comercial e Importadora Ltda. Company will make collection for later return to the manufacturer.

Device

Product name: Disposable Stylus Technical Name: Biscuit ANVISA Registration Number: 10229650002 H...

Manufacturer

Cirúrgica Brasil Comercial e Importadora Ltda.; Cirúrgica Brasil Comercial e Importadora Ltda.