Events

Alerte Ou Avis De Sécurité sur Solus Flexible Wire Reinforced Laryngeal Mask Airway

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 Intersurgical.

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
  • Date
    2017-06-09
  • Date de publication de l'événement
    2017-06-09
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/solus-flexible-wire-reinforced-laryngeal-mask-airway-risk-of-hypoxia-due-to-partial-or-total-occlusion-of-the-airway-tube-after-inflating-the-cuff
  • 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
    Manufactured by intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
  • Action
    Identify affected devices (see below) and stop using them. Quarantine and destroy all affected devices in stock. Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.

Device

Solus Flexible Wire Reinforced Laryngeal Mask Airway
  • Modèle / numéro de série
  • Description du dispositif
    The following models and LOT numbers are affected:Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2 Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5 Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3 Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4 Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5LOT numbers: from 31310139 to 31703855 inclusive.REF numbers NHS Supply Chain Codes Scottish NDC Codes 8002001 FDD1640 n/a 8025001 FDD1641 n/a 8003001 FDD1642 NDC SKU 057290 8004001 FDD1643 NDC SKU 057306 8005001 FDD1644 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Adresse du fabricant
    Intersurgical Ltd Telephone: 0118 9656 300 Fax: 0118 9656 356Email: info@intersurgical.co.uk
  • Société-mère du fabricant (2017)
    Etablissement Cosmeplast
  • Source
    MHRA