Events

Safety Alert Or Field Safety Notices for Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2

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/2014/043
  • Event Number
    CON478816
  • Date
    2014-11-25
  • Event Date Posted
    2014-11-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON478816?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) is aware of mould growth on these neonatal and paediatric support devices. the mould has been identified as cladosporium and penicillium fungi. the manufacturer has issued a revised field safety notice (fsn) dated 10 october 2014.
  • Action
    Stop using all these devices, even if you can’t see any mould on them. Dispose of all the devices according to your local environmental guidelines. Fill in the customer reply form attached to the FSN and return it to your distributor. This MDA replaces MDA/2014/038 (issued 30 September 2014).

Device

Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Neonatal and paediatric support devices. All batches of: Gel-E Donut part numbers: 92025-A, 92025-B, 92025-C and Squishon 2 part number 91033-2. These gel-filled products are 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