Events

Retiro De Equipo (Recall) de RENOSKIN

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Perugia Plastie Company.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2008-04-01
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-matrices-composites-pour-la-regeneration-dermique-renoskin-societe-perouse-plastie
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On 29/03/2008, the company Perugia Plastie Company withdrew from the market the batches of the references contained in the attached message of the medical device called composite matrices for dermal regeneration RENOSKIN, manufactured by Perouse Plastie. This withdrawal follows a few cases reporting difficulties rehydrating the matrix detected during a prospective follow-up on these medical devices. In the event of recent implantation of a device whose hydration would not have been optimal, a risk of slowing or absence of colonization of the matrix could be observed locally and generate a potential risk of localized infection. Perouse Plastie has directly notified the recipients of the incriminated lots with the enclosed message (01/04/2008) (30 ko) validated by Afssaps. This information is addressed to the directors, correspondents of materiovigilance, plastic surgeons and pharmacists responsible for sterile medical devices for dissemination where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

RENOSKIN

Manufacturer

Perugia Plastie Company
  • Source
    LAANSM