Events

Alerta De Seguridad para Commercial Name: Curatec Compressed with Petrolatum Emulsion Technical Name: Dressing ANVISA Registration Number: 80246910006 Hazard Class: III /// Models / Lots Affected: Model (7.6 x 7.6 cm): 16041204, 16041304, 16041404 and 16041503 + Model (7.6 x 20.3 cm): 16040803 +. Model (7.6 x 20.3 cm 3 um): 16040705 + Model (7.6 x 40.6 cm): 16041211

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 Indústria 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
    2032
  • Fecha
    2016-09-05
  • 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
    Do not use the product with suspected quality misuse; In case of use of the product containing any metallic fragment remove immediately from the wound cleaning the lesion with a jet of physiological solution. /// Models / Lots Affected: Model (7.6 x 7.6 cm): 16041204, 16041304, 16041404 and 16041503 Model (7.6 x 20.3 cm): 16040803 Model (7.6 x 20.3 cm) 3 um): 16040705 Model (7.6 x 40.6 cm): 16041211
  • Causa
    It was evidenced during inspection of process control in lot 16042803 of the product curatec compressa de petrolatum emulsion presence of metallic fragments coming from the rayon fabric (being opened the nonconformity number 58/16). as several batches of finished product used same batch of raw material, the company decided to segregate all batches with suspicion as well as collect what had already been marketed. investigation was made and detected that the metal fragments are sourced from the needle during the outsourced rayon weaving process. from the observation of this risk, lm farma implemented a metal-detecting inspection equipment to evaluate all rayon fabrics purchased from a third-party supplier, or the products manufactured therefrom (curatec emulsion with petrolatum and curatec age 30 rayon). product risk management is being reviewed with the inclusion of a metal detector control of rayon fabric purchased from that supplier.
  • Acción
    Field Action Code AC001 / 16 triggered under the responsibility of the company LM Farma. Company will make collection for return to the manufacturer.

Device

Commercial Name: Curatec Compressed with Petrolatum Emulsion Technical Name: Dressing ANVISA Regi...

Manufacturer

LM Farma Indústria e Comércio Ltda.