Events

Alerte De Sécurité sur MALE CONTAINER GOOD AROMATIZED AND GOOD LUBRICATED - Record 80477940001 - All lots.

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 LAM - LÁTEX DA AMAZÔNIA LIMITADA.

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
    1086
  • Date
    2011-08-10
  • 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
    According to RDC 62 of September 3, 2008, male condoms of natural rubber latex must also meet the requirements of certification of conformity under the Brazilian System of Conformity Assessment (SBAC). ### UPDATE - 10/01/2012 - The Certification Body - IFBQ, communicates (Ref. 6192/2011) that corrective actions in the production process have met the regulatory specifications. There is no more restriction on the marketing and use of the products as of this date. ### UPDATE - 08/16/2012 - The Certification Body - IFBQ, communicates (Ref. 1876/2012) that the Authorization for use is suspended for UPDATE - Publication of Resolution RE 4.944 / 2013, dated 12/23/2013, determining the suspension of the manufacture, sale, distribution, use and disclosure of the product, as well as its collection. #######
  • Cause
    Disapproval in the annual maintenance tests on the attributes of volumetric capacity and ambient and aging burst pressure as shown in test reports ela / l-209.263 / 1/11 and ela / l-209.878 / 11. ## update - 08/16/2012 - the certification body (ifbq) hereby informs (ref. 1876/2012) that the authorization for use is suspended due to the failure to perform the annual maintenance tests. ### update - publication of resolution re 4.944 / 2013, dated 12/23/2013, determining the suspension of the manufacture, commercialization, distribution, use and disclosure of the product, as well as its collection. #######.
  • Action
    To the services, professionals and users, verify the existence of this product in its stocks, segregate it in order to avoid its use and contact its supplier for collection and or replacement and reimbursement.

Device

MALE CONTAINER GOOD AROMATIZED AND GOOD LUBRICATED - Record 80477940001 - All lots.

Manufacturer

LAM - LÁTEX DA AMAZÔNIA LIMITADA
  • Source
    ANVSANVISA