Events

Safety Alert for RENASYS - G Kit with sterile gauze base

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Smith & Nephew Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1608-321
  • Event Number
    2010DM-0005709
  • Date
    2016-08-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    66020933, 66020934, 66020935, 66020936, 66800394, 66800494, 66800495, 66800496, 66800497, 66800932, || 66800933, 66800934, 66800935, 66800936, 66801255, || 66801256, 66801257 and 66801258, specific lots.
  • Product Description
    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.