Events

Alerta De Seguridad para NITINOL GUIDE FOR CATETER URODRAIN PROMEDON Technical Name: Catheter Introductory Guide ANVISA Registration Number: 10306840122 Hazard Class: II Affected Model: G-35-150S-NIT Serial Numbers Affected: Code: G-35- 150S-NIT Lots: 30892 to 30901; 31103 to 31106; 31109 to 31110; 31113 to 31115; 31430 to 31442; 31484; 31777 to 31789; 31907; 32138; 32139 to 32144; 32147; 32306 to 32311; 32614 to 32619 and 32680.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES; Promedon S.A..

¿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
    2316
  • Fecha
    2017-06-19
  • 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
    Return of items in stock. Update of the field action: UPDATED ON 10/2/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    It was identified that there was a decrease in the hydrophilic property of the product by exposure to temperatures outside the specification during the import process.
  • Acción
    Field Action Code # 01-2017 triggered under the responsibility of the company PROMEDON DO BRASIL MEDICAL HOSPITAL PRODUCTS. Company will collect for further destruction.

Device

NITINOL GUIDE FOR CATETER URODRAIN PROMEDON Technical Name: Catheter Introductory Guide ANVISA Re...

Manufacturer

PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES; Promedon S.A.