Events

Safety Alert for Beds and stretchers for hospital use

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Stryker Medical, || Muka Metal Ticaret Ve Sanayi A.S..

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
    I1505-212
  • Event Number
    2013DM-0009676
  • Date
    2015-05-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=179
  • 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 establishes that the cable that connects the hand control with the bed, can enter the lateral displacement rail and be trapped during the movements of raising and lowering the bed, causing the exposure of the conductive filaments of the same, leading to potentially occurring events adverse effects on patients or users.

Device

Beds and stretchers for hospital use

Manufacturer

Stryker Medical, || Muka Metal Ticaret Ve Sanayi A.S.
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA