Alerta De Seguridad para (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;

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LifeNet.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    387
  • Fecha
    2002-02-15
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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.

Manufacturer

  • Source
    ANVSANVISA