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 Ethicon Endo Surgery Inc.

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 002 06 16 000
  • Event Initiated Date
    2016-06-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9451
  • 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
    Ethicon has initiated a voluntary product recall of ethicon physiomesh™ flexible composite mesh (for laparoscopic use) (“ethicon physiomesh™ composite mesh”). ethicon is recalling the product following an analysis conducted at the request of the ethicon medical safety team of unpublished data from two (2) large independent hernia registries (herniamed german registry and danish hernia database-dhdb). the recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ethicon physiomesh™ composite mesh were higher than the average rates of the comparator set of meshes among patients in these registries. based on the currently available data, ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors. consequently, ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ethicon physiomesh™ composite mesh from the global market.

Device

ETHICON PHYSIOMESH Flexible Composite Mesh

Manufacturer

Ethicon Endo Surgery Inc
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA