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 Molnlycke Health Care 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 059 07 15 000
  • Event Initiated Date
    2015-07-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7938
  • 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
    Mölnlycke health care has identified that some procedurepak® trays have been delivered with a different catheter size (19g instead of 20g).The resulting impact has been assessed some resistance when inserting the associated needle into incorrect catheter size and a potential issue when needle is being removed from catheter post procedure.

Device

ProcedurePak trays
  • Model / Serial
    ProcedurePak® trays have been delivered with a different catheter size (19G instead of 20G).
  • Product Description
    Dressings / Pads - others
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB
  • Manufacturer Parent Company (2017)
    Investor AB
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA