Events

Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumbar distractor 3.5x10 - Lot 856; HRCID11 - Fine lumbar distractor 3.5x11 - Lot 883, record 10355870048, risk class I. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine 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
    1813
  • 날짜
    2016-02-01
  • 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 the registry holder, there are no negative impacts related to the patient, because the breaks occurred in the rod near the cable, externally to the patient, without the production of debris. There are also no risks related to lack of surgery, as the manufacturer also offers a series of "monobloc" lumbar distractors (HRCIDx / x references) that can be used instead of the instruments used for this recall.
  • 원인
    According to the record holder there may be breakage of the cable of two surgical instruments that may have been caused by the soldering point or deviations in its form of use.
  • 조치
    Pick up and return to the manufacturer. Action code: 00003. It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the instruments affected to the manufacturer, as well as the replacement of the items collected to the customers. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.

Device

Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumb...

Manufacturer

Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine
  • Source
    ANVSANVISA