Events

Alerta De Seguridad para SOFTWARE, DISTRIBUTION INFORMATION PROGRAM AND COMPONENTS OF THE STAND-ALONE SYSTEM OF BLOOD BANK

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

¿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
    166
  • Fecha
    2000-10-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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 blood bank program mentioned makes a defect that does not assign all special property of donation to all donation products. the manufacturer started a removal by phone on 05 july 2000, followed by letters sent on july 7, 11 and 17, 2000. the company did not provide any information to ecri.
  • Acción
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SENT AT 7-11 AND 17 JULY 2000 FOR INFORMATION DATA MANAGEMENT. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH INFORMATION DATA MANAGEMENT BY PHONE 1 (847) 825-2300 IN THE UNITED STATES.

Device

SOFTWARE, DISTRIBUTION INFORMATION PROGRAM AND COMPONENTS OF THE STAND-ALONE SYSTEM OF BLOOD BANK

Manufacturer

INFORMATION DATA MANAGEMENT
  • Source
    ANVSANVISA