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 Coloplast A/S.

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 016 02 14 000
  • Event Initiated Date
    2014-02-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=5231
  • 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
    This fsn is to inform end-users and healthcare professionals of an update to the product’sifu.The reason for the update is the publication of the review article “consensus reviewof best practice of transanal irrigation (tai) in adults”, and postmarketing surveillance.The ifu is furtherupdated in terms of a general linguistic revision.

Device

Peristeen Anal Irrigation System
  • Model / Serial
    all lot numbers
  • Product Description
    An assembly of devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex.
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Manufacturers representative
    Al Hammad Medical Services, Riyadh, (01) 4655610
  • Source
    SFDA