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 Caresia AB.

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 022 05 12 000
  • Event Initiated Date
    2012-05-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1803
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The shower- and toilet chair purelift has a seat with an intimate recess and a toilet hole. the toilet hole can be covered with a lid. is the product used for toileting the lid is removed. the function of the intimate recess is to enable easier access and better cleaning while assisting toileting. it has come to caresia attention that a patient at one time (1) has pressed his thigh into the intimate recess during toileting. the patient’s thigh was caught in the intimate recess and the patients had to be helped by the staff to get his thigh free again.

Device

Bath/shower chair
  • Model / Serial
    Purelift 62242-00
  • Product Description
    Chair, shower
  • Manufacturer
    Caresia AB

Manufacturer

Caresia AB
  • Source
    SFDA