Events

Safety Alert for Latex Surgical Gloves MADHOS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hebei Baimei Latex Products Co., Ltd.

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
    R1707-270
  • Event Number
    2015DM-0013584
  • Date
    2017-07-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=80
  • 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 invima reported that a sample of the referenced device does not comply with the orifice absence test, causing possible filtration and contact with potentially dangerous bodily fluids, leading to possible adverse events on the user and the patient.

Device

Latex Surgical Gloves MADHOS
  • Model / Serial
    lot 20160510
  • Product Description
    They allow to maintain the asepsis when the natural barriers of the skin or mucous membranes are broken. Indicated in surgical interventions and catheterizations. Used by health personnel. Used on the hands as a biological barrier.
  • Manufacturer
    Hebei Baimei Latex Products Co., Ltd

Manufacturer

Hebei Baimei Latex Products Co., Ltd
  • Source
    NIDFSINVIMA