Events

Safety Alert for Mucosal Intranasal Atomization Device MAD NASAL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Wolfe Tory Medical 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
    R1710-501
  • Event Number
    2016DM-0014759
  • Date
    2017-10-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=66
  • 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 some of the referenced devices are not completely atomizing, so that it may impair the effectiveness of the medication with which it is used, leading to possible delays in the procedures, ineffectiveness of the treatment and adverse events on the patients.

Device

Mucosal Intranasal Atomization Device MAD NASAL
  • Model / Serial
    MAD300, lot 160422
  • Product Description
    The present sanitary registry covers the following references: MAD100 (WITH 3 ML SYRINGE), MAD100OS (WITH 3ML ORALSYRINGE), MAD110 (WITH 1ML SYRINGE), MAD110OS (WITH 1MLORAL SYRINGE), MAD130 (WITH 1ML SYRINGE AND VIALADAPTER), MAD130OS (WITH 1ML ORAL SYRINGE AND VIALADAPTER), MAD140 (WITH 3ML SYRINGE AND VIAL ADAPTER), MAD140OS (WITH 3ML ORAL SYRINGE AND VIAL ADAPTER), MAD300 (WITHOUT SYRINGE), MAD800 (WITH 3ML SYRINGE), MAD900 (WITHOUT SYRINGE).
  • Manufacturer
    Wolfe Tory Medical Inc

Manufacturer

Wolfe Tory Medical Inc
  • Source
    NIDFSINVIMA