Events

Alerte Ou Avis De Sécurité sur Gel-E Donut, Squishon 2

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Philips Healthcare (Children’s Medical Ventures).

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/038
  • Numéro de l'événement
    CON459475
  • Date
    2014-09-30
  • Date de publication de l'événement
    2014-09-30
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON459475?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    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)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRA