Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Joerns Healthcare Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 120 05 18 000
  • Event Initiated Date
    2018-05-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12674
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The joerns healthcare p.R.O. matt and procair mattresses utilize pressure redistribution optimization (p.R.O.) technology, this technology requires no adjustments or external inflation devices. these non-powered air surfaces feature air cells with an inner air cell foam core and are designed to provide optimal interface pressures through controlled intake of ambient pressure (cell inflation) when there is no patient on the mattress and prevent loss of cell air when a patient is present providing therapeutic value. these mattresses are indicated as a treatment for stages i and ii pressure injuries.

Device

P.R.O. Matt and ProCair Mattresses
  • Model / Serial
    P.R.O. Matt and ProCair Mattresses manufactured from November 27, 2017 thru February 20, 2018.
  • Product Description
    Mattress
  • Manufacturer
    Joerns Healthcare Limited

Manufacturer

Joerns Healthcare Limited
  • Manufacturer Parent Company (2017)
    Joerns Healthcare Limited
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA