Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Aesculap.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 094 04 18 000
  • Fecha de inicio del evento
    2018-04-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12482
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The aesculap ag received feedback from the market that the plastic sleeves of a strauss penis clamp 130mm - ef401r had stuck together after reprocessing. during complaint investigation it has been determined that the plastic sleeves of the returned instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. internal investigation conducted at the manufacturing plant revealed that the reported failure can be limited to the production period from february 2016 to october 2017. a definite identification of an affected product is not possible without the help of suitable equipment. we therefore ask you to consider all of your existing strauss penis clamp 130mm - ef401r to be potentially affected. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to our internal distribution information your facility received applicable unit/s manufactured within the above mentioned production period. we kindly ask you to check if an affected instrument is currently in use at your facility. in case you have located an affected product: please ensure that these instruments are no longer used.

Device

Surgical PENIS CLAMP
  • Modelo / Serial
    EF401R
  • Descripción del producto
    Surgical PENIS CLAMP
  • Manufacturer
    Aesculap

Manufacturer

Aesculap