Events

Alerta De Seguridad para GYNECARE MORCELLEX FABRIC LAYER - Models MX0100, MX0100R - Register 80145901131 and GYNECARE X-TRACT LAPAROSCOPY FRAGMENTER - Models MD0100, DV0015, MD0120 - Record 10132590592

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1384
  • Fecha
    2014-05-06
  • 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
    The company reports in the general population, the use of tissue morbidity has been associated with collateral injuries such as small, broad vascular structures of the bladder, ureter, kidney and diaphragm. These complications only occur under special circumstances, since, according to the surgeon's instructions, the tissue must be completely exposed before application of the device, according to instructions for use. The reevaluation of epidemiological data leads us to conclude that the rate of probability of sarcoma in a population submitted to hysterectomy for a benign indication can be as high as 0.2%. Therefore, the probability of death, permanent disability and / or need for surgical intervention is higher, that is, it is an event for which the result of injury is expected, but only occasionally. According to the FDA, electrical morbidity may still be the best therapeutic option for some patients after a cautious evaluation of benefit-risk and signing of the informed consent term.
  • Causa
    Johnson & johnson do brasil ind. and com. de prod. for health ltda has issued a safety alert on gynecare morcellex tissue morcorator products and gynecare x-tract laparoscopy fragmenter, stating that until recently, women were commonly advised of the risk of malignancy in a myoma that is 1 in 10,000. [hampton t. 2014]. this rate is currently under debate. in order to align with the fda's recent safety communication we have decided to suspend the marketing of our morcellating products while the role of morcelation for patients with symptomatic fibrotic diseases is redefined by the fda and the medical community. in light of the fda's april 17 public communication discouraging the use of morcelation during hysterectomies or laparoscopic myomectomies, we believe that suspending the marketing of these products until their role is better understood and redefined by the medical community is the appropriate course of action in this time. it is important to note that ethicon morcelling devices have always included care in their instructions for use (ifu) on the possible spread of malignant (or suspected malignant) tissue. also, please note that we are not removing the product on the market at this time.
  • Acción
    The company directs that the customer who owns the product should only distribute this notification to all users of the Ethicon Moratorium Devices at their facility. Because this decision is not related to safety or efficacy, it is not necessary for customers who own these products to take any action such as returning or stopping the product. See Annexes: Distribution List (Annex I) and Letter to the Client (Annex II).

Device

GYNECARE MORCELLEX FABRIC LAYER - Models MX0100, MX0100R - Register 80145901131 and GYNECARE X-TR...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda