Events

Alerte De Sécurité sur (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;

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par LifeNet.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    387
  • Date
    2002-02-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
  • Manufacturer
    LifeNet

Manufacturer

LifeNet
  • Source
    ANVSANVISA