Events

Alerta De Seguridad para (1) 1G GEL-FOAM PITCH WITH HEMOSTATIC POWDER; GAZES WITH STEREO GEL-FOAMS OF SIZES: (2) 12-7MM, (3) 2CM, (4) DENTAL PACKAGES 4CM. ALL NUMBERS OF LOTS (> 1.5 MILLION DISTRIBUTED SINCE 1995 IN BRAZIL AND WORLDWIDE

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

¿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
    13
  • Fecha
    2001-03-14
  • 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
    Aluminum filiformes fragments of potes beads were detected on powder and gazes.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWAL ON NOVEMBER 17, 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED THE NOTIFICATION OF THE PHARMACY. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. FOR FURTHER INFORMATION, TELEPHONE TO PHARMACY, 00XX1 (908) 901-8000.

Device

(1) 1G GEL-FOAM PITCH WITH HEMOSTATIC POWDER; GAZES WITH STEREO GEL-FOAMS OF SIZES: (2) 12-7MM, (...

Manufacturer

PHARMACIA CORP.
  • Source
    ANVSANVISA