Events

(1) Cancellous, (2) Cardiovascular, (3) Demineralized Ground Cortical, (4) Fascia Can, (5) Femoral Heads, (6) Femoral Shafts, (7) Fibulas, Humeral Heads, (9) Iliac Crest Wedges, (10) Ilium Strips, (11) Nondemineralized Ground Cortical, (12) Patellar Ligaments, (13) Patellar Wedges, (14) Pericardium, (15) Pulmonary Patch Grafts, Vertigrafts. US-ID: 98-0206-001, 98-0206-002, 98-0206-004 to 98-0206-006, 98-0206-010 to 98-0206-017, 98-0206-030 to 98-0206- 034, 98-0385-001 to 98-0385-010, 98-0385-014 to 98-0385-029, 98-0385B-008 to 98-0385B-062, 98-0385B-065 to 98-0385B-209, 98-0476-001 to 98-0476-008, 98-0476-010 to 98-0476-029, 98-0476B-013 to 98-0476B-109, 98-0476B-112 to 98-0476B-238, 98- 0476B-240 to 98-0476B-250, 98-1517-001 to 98-1517-006, 98-1517-010, 98-1517-011, 98-1517-013 to 98-1517-018, 98-1517- 024 to 98-1517-027, 98-1517-029 to 98-1517-045, 98-1517B-003 V 98-1517B-092, 98-1517B-098 to 98-1517B-177, 99-0237-001 to 99-0237-013, 99-0237-016 to 99-0237-022, 99-0237-028, 99-0237-029, 99-0237-032, 99-0237-034 to 99-0237-038, 0237-041 to 99-0237-057, 99-0522-001 to 99-0522-014, 99-1630-001 to 99-1630-005, 99-1630-016 to 99-1630-018; 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 LifeNet 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
    387
  • 날짜
    2002-02-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    The above tissues may have been collected from donors who were not properly evaluated. the manufacturer initiated a correction by letter dated october 16, 2001.
  • 조치
    Make sure you have received the letter dated October 16, 2001 from LifeNet. Identify and isolate any affected product in your inventory. For more information, contact LifeNet by phone at (1757) 464-4761 within the US or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

(1) Cancellous, (2) Cardiovascular, (3) Demineralized Ground Cortical, (4) Fascia Can, (5) Femora...
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Source
    ANVSANVISA