Alerta De Seguridad para Glove for Non-Surgical Procedure with powder - Registration No. 10330660014, Sizes PP, P, M, G

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Top Glove SDN BHD; Descarpack Descartáveis do Brasil 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The semi-annual maintenance tests indicated that the sample analyzed does not meet the microbiological requirements of INMETRO Ordinance no. 322 of June 26, 2012. The health services that have the product in stock must segregate the samples so that the registry holder can proceed with the collection. ////// UPDATE - 04/17/2014 - The company informs that considering that gloves tested are Gloves for Non-Surgical Procedures, and that, due to their own instructions for use, Gloves for Non-Surgical Procedures Descarpack are not used in invasive procedures where controlled microbiological requirements are paramount. According to the American Pharmacopoeia, USP, non-sterile products are used in regions of the human body that are rich in bacterial flora and have physical or immunological barriers to infection. Examples cited are the oral cavity, skin, nasopharynx, rectum among others, which harbor a high and diversified viable microbial population. Recent studies carried out from the Human Microbiome Project underline the enormous size and diversity of human-associated bacterial populations. A healthy adult has a bacterial population of approximately 1014 bacteria, a number that exceeds the subject's own cells by a factor of 10. In addition, according to the results of test reports MIC-L-241861/1/14 (test) and 244561/1/14 (counter-proof) issued by the Instituto Falcão Bauer da Qualidade (IFBQ), pathogenic microorganisms were not found in the gloves. ///// UPDATE - 08/13/2014 - The company sent a report of completion of the field action, all customers were informed of the action of collection, and collected 135,388 cartridges of the lots involved in this field action.) / /// UPDATE 10/20/2014 - The IFBQ revoked the suspension of the Authorization for the use of the Conformity Identification Seal, in order to carry out all necessary actions and approval in the tests provided for in the Conformity Assessment Regulations, carried out in samples produced after corrective actions.
  • Causa
    Suspension of the authorization for the use of the identification seal by the product certification body (ocp) for failure to perform the bi-annual maintenance tests in the microbiological attribute, according to reports micl / l-241861/1/14, mic / l-244561/1/14, mic / l-244561/2/14, mic / l-244585/1/14, mic / l-244760/1/2/14, issued by the ocp.
  • Acción
    Company shall trigger a Field Action for the collection of the product, from the date of the last analysis of maintenance of the certification, occurred on 01/04/2013. All batches manufactured from this date must be collected from the market. /////// UPDATE 04/17/2014 - The company sent a copy of the letter sent to the distributors informing about the field action and the list of the lots imported in the period and that are the target of this collection (see ANNEX I) ./ //// UPDATE 10/20/2014 - The IFBQ, certifying body, issued document Ref.1563 / 2014 notifying the revocation of the suspension of the Authorization to use the Conformity Identification Seal.