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 ConMed Linvatec Corporation.

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 037 06 13 000
  • Event Initiated Date
    2013-06-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3717
  • 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 issue was confirmed through in-house testing. it was determined that an internal assembled component (molded fitting, part number a41-001-007, fitting, pev barb-female, print enclosed) contained a scratch/grooved area on the inside diameter of the fitting that may cause the apex irrigation pump to sense a pressure drop and increase fluid flow to the surgical site.

Device

ARTHROSCOPY , C7120 APEX® Arthroscopy Tubing Set, One
  • Model / Serial
    Item numbers C7120 and C7122 APEX ® Arthroscopy Tubing Sets
  • Product Description
    Treatment of damage of the interior of a joint is performed using an arthroscope
  • Manufacturer
    ConMed Linvatec Corporation

Manufacturer

ConMed Linvatec Corporation
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Manufacturers representative
    Al Ewan Medical Company , Riyadh , (011)4563366
  • Source
    SFDA