Events

Alerta De Seguridad para INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS SYSTEMS

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por (1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NEPHEW PLC; (5) STRATEC MEDICAL LTDA.; (6) STRYKER HOWMEDICA OSTEONICS DIV STRYKER CORP.; (7) ZIMMER 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
    44
  • Fecha
    2001-06-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Medical devices agency, mda / uk, laid an alert due to the report of a fatal incident, in which a canulated drill went into the introduction guide and advanced about the pelvis reaching the ilíaca veia. mda alert on the risk of advancing guidelines for underlying tissues during procedures involving insertion, scratching, inserting screws and screwing through guides with canulated instruments.
  • Acción
    MEDICAL DEVICES AGENCY, MDA / UK, RECOMMENDS THAT PROFESSIONALS: (1) VERIFY THE POSITION OF THE INTRODUCTION GUIDELINES WITH IMAGE INTENSIFIER (FLUOROSCOPY) FREQUENTLY TO AVOID ADVANCEMENT AND PENETRATION IN THE ADJACENT FABRICS. (2) CLEANING THE CANULATED INSTRUMENTS DURING OPERATION TO AVOID BONE PARTICULATE ACULVULATION IN THE CELL. FOR TECHNICAL INVESTIGATIONS, MEDICAL DEVICES AGENCY, MDA / UK, HAS PLACED TWO EXPERTS IN DISPOSAL, DRS. J. COOKE OR DR. J. SHAW (FAX: 0021-44-207-972-8106, PHONE 0021-44-207-972-8267 OR 8343 OR MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR CLINICAL RESEARCH, DR. J. HOPPER (FAX: 0021-44-207-972-8103, PHONE 0021-44-207-972-8126 OR BY MAIL, HANNIBAL HOUSE, ELEPHANT AND CASTLE, LONDON SE1 6TQ, ENGLAND). FOR ALL INVESTIGATIONS, CIT THE REFERENCE NO. 20000519011-8.

Device

INTRODUCTION GUIDELINES USED IN ORTHOPEDICS AND TRAUMATOLOGY FOR THE GUIDED CANULATION OF SCREWS ...

Manufacturer

(1) B BRAUN MEDICAL LTDA.; (2) BIOMET MERCK LTDA.; (3) DE PUY INTERNATIONAL LTDA.; (4) SMITH & NE...
  • Source
    ANVSANVISA