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 PAUL HARTMANN.

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 032 07 13 000
  • Event Initiated Date
    2013-07-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3879
  • 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
    A quality inspection revealed the individual occurrence of micro-holes in a number of blisters (sterile packaging) containing terile surgical gowns and isolation gowns. the micro-holes are unlikely to be detected through visual inspection. as a result, the sterility of affected products may be compromised.

Device

Folio dress gown Comfort Basic
  • Model / Serial
    See attached
  • Product Description
    sterile, Single-use
  • Manufacturer
    PAUL HARTMANN

Manufacturer

PAUL HARTMANN
  • Manufacturer Parent Company (2017)
    Schwenk Limes Gmbh & Co. Kg
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB, Riyadh, (011) 4771374
  • Source
    SFDA