Events

Alerte De Sécurité sur Product Name: Intracranial Clip for Brain Aneurysm Titanium ADCA //. Risk class: IV (Maximum Risk) //. Technical name: Intracranial clip for cerebral titanium aneurysm //. Registration number: 80116050002 //. Affected model (s): MXT016; MXT058: MXT116; MXT117; MXT143. Lot (s): All lots series 0010-2016; 0011-2016; 0020-2016; 0045-2016; 0046-2016; 0049-2016; 0067-2016; 0068-2016; 0070-2016; 0107-2016; 0126-2016; 0159-2016; 0178-2016; 0187-2016; 0222-2016 //. Attached traceability listing of affected clips

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 ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO 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
    1957
  • Date
    2016-08-01
  • 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
    The company ADCA will carry out a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information. The ADCA will send to the health facilities the traceability labels with the correct registration number along with guidelines for corrections to the medical charts and records of the patients. However, ADCA recommends that patients and users who have used the series of products checked, contact ADCA customer service channels at (31) 3496-1855 or by e-mail sac@adca.ind.br, so that they can learn how and when the traceability labels will be made available for field correction.
  • Cause
    Some batches of adca clips whose references are mxt016; mxt058; mxt116; mxt117 and mxt143 had their external labels and trace labels printed with the wrong registration number. the registration number printed on the outer label and on the trace labels was 80116050003, which corresponds to the adca force clip, when the correct registration number to be printed would be 80116050002, corresponding to the adca aneurysm clips.
  • Action
    Field Action No. 01/2016 triggered under the responsibility of the company ADCA - INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA. The action in the field aims to promote the correction of the labels and labels of trail of the clips according to the correct registration of the product, ADCA will make a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories ; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information.

Device

Product Name: Intracranial Clip for Brain Aneurysm Titanium ADCA //. Risk class: IV (Maximum Risk...

Manufacturer

ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA
  • Source
    ANVSANVISA