Events

Alerta De Seguridad para RENASYS - G Kit with sterile gauze base

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Smith & Nephew 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
    R1608-321
  • Número del evento
    2010DM-0005709
  • Fecha
    2016-08-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that the referenced devices may have the sterile barrier compromised, leading to its use may cause possible adverse events on patients.

Device

RENASYS - G Kit with sterile gauze base
  • Modelo / Serial
    66020933, 66020934, 66020935, 66020936, 66800394, 66800494, 66800495, 66800496, 66800497, 66800932, || 66800933, 66800934, 66800935, 66800936, 66801255, || 66801256, 66801257 and 66801258, specific lots.
  • Descripción del producto
    The RENASYS - G Kit with sterile gauze base SMITH & NEPHEW. It is used in conjunction with the wound pressure treatment system to deliver a negative pressure to a wound site for the healing effects of the wound itself. The RENASYS - G: with sterile gauze base SMTTH & NEPHEW will be used with negative pressure system to deliver negative pressure in the wound. SMITH & NEPHEW NPWT system indicated for patients who will benefit from a suction device (negative pressure), since any promotion of wound healing through the elimination of liquid risk and body fluids, wound exudates and infectious material. NPWT is appropriate for use in the following types of injuries: chronic, acute, traumatic, sub-acute and dehiscence of wounds, ulcers (such as hypertension or ladiabetes). Partial thickness burns. flaps and grafts.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.