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 3M ESPE Dental Products.

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 051 12 13 000
  • Event Initiated Date
    2013-12-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4906
  • 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 ingredient that gives hydrophilic properties to this impression material was left out of the formulation. the two different trade names and corresponding lot numbers are listed above.

Device

IMPRINT™ II Regular Body VPS Impression Material, PARADIGM™ Regular Body VPS Impression Material
  • Model / Serial
    IMPRINT™ II Regular Body VPS Impression Material Refill 4-PACK Catalog Number 9379, Lot Codes N510884 and N510889 PARADIGM™ Regular Body VPS Impression Material Refill 2-PACK Catalog Number 5315, Lot Code N511952
  • Product Description
    Crown and bridge impressions, Inlay and onlay impressions, Functional impressions, Denture and partial denture impressions
  • Manufacturer
    3M ESPE Dental Products

Manufacturer

3M ESPE Dental Products
  • Manufacturer Parent Company (2017)
    3m Company
  • Manufacturers representative
    Thimar Al Jazirah Healthcare Co., +966558311166
  • Source
    SFDA