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 Coloplast A/S.

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 035 01 11 000
  • Event Initiated Date
    2011-01-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=50
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    There is a potential risk of bowel perforation during trans anal irrigation or any other device for rectal insertion in general, whether using products with or without a flange which limits insertion depth. the company do not consider that the addition of a flange would eliminate the risk. a change to the design of the product has not been pursued and risk control measures concentrate on training and the precautions and contraindications contained in the instructions for use.

Device

Peristeen Anal Irrigation System.
  • Model / Serial
  • Product Description
    An assembly of devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence
  • Manufacturer
    Coloplast A/S

Manufacturer

Coloplast A/S
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Manufacturers representative
    Al Hammad Medical Services, Riyadh, (01) 4655610
  • Source
    SFDA