Events

Notificaciones De Seguridad De Campo acerca de Sinaqua Dermal Glove, Sinaqua Wipe as well as Easyderm Glove

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 WELCARE INDUSTRIES S.p.A..

¿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
    2016-07-25
  • 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
    We have become aware that a custom-made version of sinaqua dermal glove , produced for another country, has been contaminated with burkholderia cepacia. as a precaution, we are withdrawing all the lots of sinaqua dermal glove as well as sinaqua wipe and easyderm glove . the lot numbers are indicated above. potential risk sinaqua dermal glove is a class i, non sterile, premoistened glove for cleansing intact skin. should the device be contaminated with burkholderia cepacia, the bacteria poses no/ little medical risk to healthy people. however, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to respiratory infections, keeping in mind that the effects of b. cepacia vary widely.

Device

Sinaqua Dermal Glove, Sinaqua Wipe as well as Easyderm Glove

Manufacturer

WELCARE INDUSTRIES S.p.A.