Events

Safety Alert for WELL MEDICINE Sterile Glove

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Suzhou Hengxiang Import & Export 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
    R1705-191
  • Event Number
    2014DM-0011686
  • Date
    2017-05-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=85
  • 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 leakage and contact with potentially dangerous body fluids, leading to possible adverse events on the user and the patient.

Device

WELL MEDICINE Sterile Glove
  • Model / Serial
  • Product Description
    Sterile disposable gloves that completely cover the hands to generate a barrier against potentially infectious materials and other contaminants.
  • Manufacturer
    Suzhou Hengxiang Import & Export Co, Ltd.

Manufacturer

Suzhou Hengxiang Import & Export Co, Ltd.