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Historias - Patients harmed by medical devices
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Notificaciones De Seguridad De Campo acerca de Static Mattresses
Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Park House Healthcare Ltd..
¿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
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Número del evento
SN2011(22)
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Fecha
2011-08-24
- País del evento
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Fuente del evento
HPRA
- URL de la fuente del evento
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Notas / Alertas
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland." -
Notas adicionales en la data
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Causa
Park house healthcare has issued a field safety notice (fsn) to notify users of the availability of an updated guide to correct mattress usage.
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Acción
Park House Healthcare issued a FSN and copy of the updated guide to customers who purchased mattresses within the time period 2005 – 2009. The Irish Medicines Board (IMB) advises that users: • Identify the devices in your facility, which are within the scope of this field safety corrective action (FSCA). • If you have devices affected by this FSCA, follow the manufacturer’s recommendations, as outlined in the attached FSN. • Maintain awareness of the updated guide within your facility and return the fax back form to Park House Healthcare, or your distributor, if you have not already done so
Device
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Modelo / Serial
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Descripción del producto
Static Mattresses
- Manufacturer
Manufacturer
- Empresa matriz del fabricante (2017)
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Source
HPRA