Events

Alerta De Seguridad para Trade name: Curatec Curing Activated Charcoal. ANVISA registration number: 80246910011. Risk class: III. Affected model (s): 10 cm x 10 cm. Lot (s) / Serial Number (s) Affected: 16080805/16071804/16090608

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LM Farma Industria e Comércio Ltda.

¿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
    2045
  • Fecha
    2016-11-24
  • 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
    According to the manufacturer: It is important to note that no complaint or claim of the market regarding this risk has been registered so far. In this way it is a voluntary and totally preventive recall. In the case of a distributor, who is not the final customer, we kindly request that the collection of the above lots be done also with its customers. The return of the product must be made to LM Farma by invoice of return.
  • Causa
    The company lm farma, during the process of validation of a new envelope size, through the methylene blue dye test performed exclusively in validations, evidenced the formation of microchannels at the point of intersection between the supplier's seal (amcor) and the sealing performed internally by the company lm farma. non-compliance number 155/16 was opened and during the batch investigation it was found that the packaging material in use is subject to interference by small processing variations in each sealing equipment (time, pressure, temperature, rubber and sealing bar, alignment of the beat between the cheeks, weight and type of material used), until then categorized in the same group.
  • Acción
    Field Action Classification: Pickup, Return to Manufacturer Field Action Code: AC005 / 16. Recommendations to users and patients: Risks to the patient: The sealing of the envelope forms a barrier to preserve the sterility of the product. The use of a non-sterile product could expose more debilitated patients to the risk of infection. Necessary measures: Do not use the product with suspected quality deviations; Inform available stock for LM Farma to expedite the replacement of products to be collected.

Device

Trade name: Curatec Curing Activated Charcoal. ANVISA registration number: 80246910011. Risk clas...

Manufacturer

LM Farma Industria e Comércio Ltda