Events

Notificaciones De Seguridad De Campo acerca de MAD Nasal™ Intranasal Mucosal Atomization Device

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Teleflex Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-10-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Teleflex medical has decided to recall the above products because it may not be possible for the product to deliver a fully dispersed nebula drug. teleflex medical has received complaints that the affected batch of products produces a flat stream instead of a diffused mist of medicine. if the device does not deliver the mist of the sprayed drug, this may adversely affect the performance of the drug used on the device. this can lead to serious injury or death in certain emergencies when the device is used in a non-indicated mode, such as delivering drugs without a needle to save a life-threatening drug overdose, to save a life in the event of a severe hypoglycemia or treatment of seizures.

Device

MAD Nasal™ Intranasal Mucosal Atomization Device
  • Modelo / Serial
    MAD100 160105 MAD130OS 160436 MAD300 160409 160137 160803 160422 160302 MAD140 160125 160432 160321 160218 160440 160402 160437 160500 160435 160610 160518 160506 160801 160602 160523 MAD140OS 160226 160611 160609 160438 160621 160620 160727 160631 160707 MAD300 160108 160701 160802 160117 160708 160813 160126 160718 MAD100OS 160322 160145 160728 160524 160146 160800 160630 160200 160804 MAD110 160217 160219 160814 160507 160225 160816 MAD110OS 160240 160231 160823 160312 160300 MAD300B 160410 MAD130 160107 160313 160138 160327 160517 160400
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical