Events

Alerta De Seguridad para STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC.

¿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
    157
  • Fecha
    2000-06-19
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above mentioned nerve locator can operate intermittently, which may result in a lack of perception of stimulus when the nervous tissue is really touched by the stimulator. this false-negative response may be interpreted as the absence of nervous tissue. the manufacturer started a removal by correspondence dated of june 19, 2000.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE DATED CORRESPONDENCE OF JUNE 19, 2000 AND THE MEDTRONIC XOMED SURGICAL PRODUCTS CHECKLIST. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY USING THE CHECKLIST. RETURN THE PRODUCT AFFECTED FOR MEDTRONIC XOMED SURGICAL PRODUCTS AT THE ADDRESS REFERRED TO. MEDTRONIC XOMED SURGICAL PRODUCTS WILL ISSUE A CREDIT OR SEND A NERVE STIMULATOR / LOCATOR FOR ANY AFFECTED PRODUCT RETURNED. WHEN YOU SEND THE AFFECTED PRODUCT, CLEARLY IDENTIFY THE EXPORT PACKAGING PARTY ON THE OUTSIDE OF THE SHIPPING PACKAGE, THE PRODUCT RETURN AUTHORIZATION NUMBER SPECIFIED IN THE NOTIFICATION LETTER AND INCLUDE A COPY OF THE CORRESPONDENCE DATE OF JUNE 19, 2000 AND THE CHECKLIST FOR RECEIPT OF THE CREDIT. FILL IN THE CHECKLIST AND FAX FOR MEDTRONIC XOMED SURGICAL PRODUCTS 1 (904) 296-2386. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH MEDTRONIC XOMED SURGICAL PRODUCTS CONSUMER SERVICE BY PHONE 1 (904) 296-9600 IN THE UNITED STATES.

Device

STIMULATOR / NERVE LOCATOR, DISPOSABLE PULSATRON LL; IDENTIFIER: NO. CATALOG 82-62015;

Manufacturer

MEDTRONIC XOMED SURGICAL PRODUCTS INC DIV MEDTRONIC INC
  • Source
    ANVSANVISA