Events

Safety Alert for Laryngeal Mask SOLUS FLEXIBLE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Intersurgical (Guernsey) Limited || Intersurgical Limited || Intersurgical S.P.A. || Haiyan Kangyuan Medical Instrument || Well Lead Medical Co Ltd || Foremount Enterprise Co Ltd || Hsiner, No. 312, Jhongshang Rd || Vitaltec Corporation || Scope Medical Devices Private Limited || Intersurgical Uab || Suzhou Weikang Medical Apparatus 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
    R1706-216
  • Event Number
    2008DM-0002807
  • Date
    2017-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • 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 has identified that due to a manufacturing defect, inflation of the cuff can reduce the cross section of the airway tube, which leads to partial or total occlusion of the airway and reduction of airflow, leading to potential adverse events are presented to patients.

Device

Laryngeal Mask SOLUS FLEXIBLE

Manufacturer

Intersurgical (Guernsey) Limited || Intersurgical Limited || Intersurgical S.P.A. || Haiyan Kangy...
  • Source
    NIDFSINVIMA