Events

Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatment Hypersensitivity Dentinaria - Risk Class: II - MEDIUM-RISK - Affected lots: 100415; 040215 (Distribution map in ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Dentscare 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
    1688
  • 날짜
    2014-09-16
  • 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 recommends "... It is recommended not to use products from batches 040215 and 100415, because the product may cause irritation to the soft tissues of the mouth. In case of suspected adverse effects mentioned in individuals subject to the use of the product, recommends clinical monitoring until remission of signs and symptoms. "
  • 원인
    Products in batches 040215 and 100415 show changes in ph content which may lead to irritation of the oral soft tissues. according to the company, to evaluate the risks involved were investigated in isolation the raw materials used in the product, but no changes were identified in the standards. we also investigated the production processes where they found that products from the milling process of hydroxyapatite had ph values ​​above the usual.
  • 조치
    Company is promoting the collection of lots under risk in Brazil, according to the Letter to Customers (APPENDIX). Code VPV001

Device

Name: Desensibilize Nano-P - Número do Registro: 80172310042 - Technical Name: Subst.P / Treatmen...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Dentscare Ltda

Manufacturer

Dentscare Ltda