Events

Alerta De Seguridad para Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registration Number: 10330710065 Hazard Class: II Affected Model: 084120 and J-BICS-058020 Affected Lot / Serial Numbers: U2412468; U2412469; U2412470; U2413367; U2413911; U2429088; U2452670; 4,946,704; 4,965,697; 4,976,258; 4999997; 4,999,998; 5003247; 5007047; 4942636; 5,138,605; 5,141,718; 5,141,199; 5,145,105; 5,149,622; 5,149,623; 5,365,572; 5,365,642; 5,370,995; 5,388,926; 5509391; 5,518,548; 5,518,549; 5,593,065; 5,684,248; 5,718,485; 5,721,755; 5,737,801; 5,744,000; 5744001; 5,743,999; 5,766,046; 5,766,047; 5,789,746; 5794877; 5,798,213; 5,826,962; 5,973,018; 6008488; 5,978,226; 6008489; 6,056,601; 6073730; 6073731; 6127074; 6131751; 6131752; 6,142,020; 6,142,021; 6146513; 6146514; 6146518; 6228742; 6,242,198; 6371295; 6,375,171; 6,396,897; 6,396,898; 6214087; 6,247,244; 6255677; 6,262,720; 6,295,798; 6653171; 6719828; 6,519,829; 6,262,338; 6,360,647; 6,360,648; 6364334; 6371297; 6371298; 6,998,469; 7,012,893; 7,016,375; 7,016,376; 7,128,835; 7,134,480; 7162449; 7162450; 7162451; 7457006

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated.

¿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
    2245
  • Fecha
    2017-03-23
  • 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
    If direct skin or patient contact with overheated devices resulting in skin damage, including burns, it is recommended to seek medical attention.
  • Causa
    The cook medical group initiated voluntary recall of bush ureter illuminating catheters (references 084120 and j-bics-05802) due to the increased number of complaints that the black conductor in the proximal portion, which connects to the transparent component of the bush ureteral illumination catheter , it can overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes in contact with the patient's urethra, bladder, and ureter.
  • Acción
    Field Action Code No.207 / RNC 031 - 032 / RA 018 triggered under the responsibility of Handle Comércio de Equipamentos Médicos Ltda. Company will collect.

Device

Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registrati...

Manufacturer

Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated
  • Source
    ANVSANVISA