Events

Safety Alert Or Field Safety Notices for Gel-E Donut, Squishon 2

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Philips Healthcare (Children’s Medical Ventures).

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
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2014/038
  • Event Number
    CON459475
  • Date
    2014-09-30
  • Event Date Posted
    2014-09-30
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON459475?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of infection, breathing difficulties and allergic reactions. philips healthcare (children’s medical ventures) has become aware of mould growth on these neonatal and paediatric support devices. the mould has been identified as cladosporium and penicillium fungi. the manufacturer sent a field safety notice (fsn) to customers in may 2014 but has not had sufficient confirmation that customers have received and acted on this notice.
  • Action
    Identify affected devices as described in the FSN. Dispose of any product containing mould according to your local environmental guidelines. Fill in the customer reply form attached to the FSN and return it to your distributor.

Device

Gel-E Donut, Squishon 2
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Neonatal and paediatric support devices Gel-E Donut, part numbers: 92025-A, 92025-B, 92025-C Squishon 2, part number: 91033-2 All batches These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body. The part number is printed on the product itself.
  • Manufacturer
    Philips Healthcare (Children’s Medical Ventures)

Manufacturer

Philips Healthcare (Children’s Medical Ventures)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA