Events

Alerta De Seguridad para Commercial Name: PHMB Antimicrobial Foam Coating Technical Name: Coverage ANVISA Registration Number: 10349000446 Hazard Class: IV Affected Model: 55511AMDX and 55512AMDX

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

¿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
    2030
  • Fecha
    2016-12-14
  • 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
    Due to divergence in the nationalization labels on the primary packaging of the 55511AMDX and 55512AMDX models of the PHMB Antimicrobial Foam Coverage product the units marketed will be recovered. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Medtronic has identified a divergence in the nationalization labels on the primary packaging of the 55511amdx and 55512amdx models of the phmb antimicrobial foam coverage product. the incorrect information detected refers to the anvisa registration number in the product, where the correct number is 10349000446. the affected units were locked in the balance available in stock, considering that they were nationalized erroneously. the commercialized units will be recovered and reworked for the labeling with the correct anvisa registration number. we clarify that the information on the secondary packaging complies with the submission of the registration to anvisa and we emphasize that there was no change in the performance, efficacy, and safety of the product to the patient.
  • Acción
    Field Action Code FA Foam Coverage with Antimicrobial PHMB triggered under the responsibility of the company AUTO SUTURE. Company will make a retraction for later reworking within the distribution center of Brazil.

Device

Commercial Name: PHMB Antimicrobial Foam Coating Technical Name: Coverage ANVISA Registration Num...

Manufacturer

AUTO SUTURE.; Medtronic
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA