Events

Alerta De Seguridad para ADJUSTABLE SILICON PLATED NICKEL THERMOPLASTIC SOCKET ADAPTERS MODEL 2065. IDENTIFIER: LOT NOS: AT 0199-2, AT 0799-8

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CENTURY XXII INNOVATIONS INC; RSLSTEEPER LTD.

¿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
    138
  • Fecha
    2000-09-22
  • 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
    The united kingdom medical equipment agency (mda) issued a security notification notice that the adapters mentioned can present a crack beginning at the alignment cab or at the back of the screw. this cracking can progress up to the total breakage could cause injury to users.
  • Acción
    MDA RECOMMENDS THAT HEALTH CARE PROVIDERS DO THE FOLLOWING: (1) NOTIFY EMPLOYEES RESPONSIBLE FOR PROVIDING, ASSEMBLING AND MAINTAINING EXTERNAL PROSTHESES OF LOWER MEMBERS USING THE AFFECTED ADAPTERS. (2) CALL THE USERS FOR REVISION OF THE ORTHOS AND REPLACE ALL EXTERNAL PROSTHESES OF THE LOWER MEMBERS USING THIS PRODUCT AFFECTED OF THE LOTS WITH THE NUMBERS MENTIONED. (3) READ THE TECHNICAL MANUAL TO ENSURE THAT THE ADAPTERS OF THE AFFECTED SOCKETS ARE PROPERLY PLACED, SINCE SOME UNITS WERE INCORRECTLY MOUNTED. REVISED ADAPTERS BRING A PRINTED TEXT IN THEM TO GUARANTEE CORRECT RADIAL LOCATION.

Device

ADJUSTABLE SILICON PLATED NICKEL THERMOPLASTIC SOCKET ADAPTERS MODEL 2065. IDENTIFIER: LOT NOS: A...

Manufacturer

CENTURY XXII INNOVATIONS INC; RSLSTEEPER LTD
  • Source
    ANVSANVISA