Events

Alerte De Sécurité sur HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://portal.anvisa.gov.br/wps/wcm/connect/29ba32804c843d149d0edd93d95c4045/Lotes+Afetados+1171.pdf?MOD=AJPERES

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda..

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
    1171
  • Date
    2012-08-28
  • 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
    Read the Letter to Customers carefully. Anvisa follows this action. http://en.wikipedia.org/w/index.php/
  • Cause
    Difficulty in firing the device, resulting in incomplete triggering and consequent incomplete stapling.
  • Action
    (1). Inspect your inventory immediately to verify that you have the affected product, and separate those products. (2). Fill out the Business Response Form and fax to INCLUDE LOCAL CONTACT, within 3 business days, even if you do not have the product affected. We request that you mention Event 7283. If you have any product to be returned, keep a copy of this form in your records. (3). To return the affected product, take a copy of the Business Response Form, place it in the box with your product, and attach the preprinted shipping label. (4). You are requested to share this information with all appropriate personnel in your facility. As with any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://po...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.