Events

Alerte De Sécurité sur Product name: Mucosal Atomization Device Technical Name: Devices ANVISA Registration Number: 80117580370 Hazard Class: I Affected Model: MADgic LMA (MAD720) Serial numbers affected: MAD720 Lot: 160404

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA; Teleflex Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2129
  • Date
    2016-12-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    1. If there are products in stock, immediately discontinue use of the product and segregate them in the quarantine and request recall. 2.To return the product, complete the recall recall form and send it to the distributor or via email recalls @ teleflex. with. This will allow you to identify the number of products in stock for return. A representative of the distributor who has carried out the commercialization of this product will contact you and guide you in the best way to return these products. 3. If you do not have any quantity of the affected product in stock, please complete the recall form, forward it to the distributor or via e-mail to recalls@teleflex.com. This will confirm that you have received this collection notice.
  • Cause
    The manufacturer teleflex has sent a statement regarding safety issues regarding investigations carried out in other countries containing product / lot sent to brazil. as part of the release, the recall of these products becomes necessary, once after investigation it has been concluded that the affected products can produce a continuous flow of medication, instead of a medication atomizer. serious health consequences are unlikely to occur in the event of failure, but this may result in inadequate topical anesthesia which may lead to discomfort, further attempts to administer topical anesthesia, or the use of alternative anesthesia methods.
  • Action
    Field Action Code RAM 15/2016 triggered under the responsibility of the company EMERGO BRAZIL IMPORT IMPORTATION AND DISTRIBUTION OF MEDICAL PRODUCTS HOSPITALARES LTDA. Company will make collection for later return to the manufacturer.

Device

Product name: Mucosal Atomization Device Technical Name: Devices ANVISA Registration Number: 8011...

Manufacturer

EMERGO BRAZIL IMPORT IMPORTAÇÃO E DISTRIBUIÇÃO DE PRODUTOS MÉDICOS HOSPITALARES LTDA; Teleflex Me...
  • Source
    ANVSANVISA