Events

Alerte De Sécurité sur SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 10237580042. Batch: BE30H / 14D01.

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 LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd..

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
    1516
  • Date
    2014-12-17
  • 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
    At the moment, no technical complaint regarding this model / batch has been registered that could offer any risk to its users. This was a field action triggered based on the information received from COVISA (SP), published in the DOC of 11/27/2014 - page 81. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action proving the destination of non-compliant products.
  • Cause
    Identified the presence of a foreign body (hair) attached to the sealing of the packaging of this needle, resulting from unsatisfactory aspect analysis.
  • Action
    The company that holds the register will collect the needles. The company advises customers to immediately discontinue the use of the product from the batch mentioned, segregating them and identifying them so that they are not inadvertently used. They will be collected and destroyed. (LETTER TO THE CUSTOMER IN ANNEX)

Device

SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 1023758...

Manufacturer

LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd.
  • Source
    ANVSANVISA