Events

Alerte De Sécurité sur MULTIPACK FOR OPTISTAR MR - Registration 80136710130 - VAZ Syringe 60ml - AFFECTED LOTS: 0130214; 0278106; 1021271; 9212120; 9260020; 9302042. MULTIPACK FOR OPTISTAR LE - Registration 80136710127 - VAZ Syringe 60ml - AFFECTED LOTS: 0008414; 0008415; 0029500; 0067043; 0078240; 0155153; 0155154; 0162123; 0235010; 0235011; 0246197; 0300142; 1007201; 1021246; 1028229; 1028232; 1035287; 1049313; 1056021; 1063220; 1070128; 1091217; 1098211; 1105219; 1147187; 1238134; 9037138; 9037139; 9058256; 9100261; 9114151; 9128089; 9163187; 9176144; 9247098; 9275102; 9310048; 9317055; 9331149; 9338345.

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 MALLINCKRODT DO BRASIL 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
    1117
  • Date
    2012-03-05
  • 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 occurrence has been identified in Japan. No known adverse events are known. There are no records in NOTIVISA. Anvisa will follow this action. #### UPDATE (09/25/2012): In a field action monitoring report, the company reported that it has collected, so far, 48,304 units of the product at risk (out of a total of 654,399 units sold in Brazil. ## CONCLUSION OF THE FIELD ACTION: According to the Field Action Completion Report (exp 0157288 / 13-1) presented by the registry holder, of the 315 clients contacted, 92 (29.2%) reported the quantity of products to be returned or consumed, and 233 did not respond.He collected 48,452 (9.5%) units, out of a total of 509,246 units sold in Brazil.The stock was closed by the company on 02.22.2013.
  • Cause
    Sterilized packages of these devices were identified that were not sealed.
  • Action
    Identify the affected products in stock, immediately discontinue use, segregate products, and complete the Customer Return Form for return.

Device

MULTIPACK FOR OPTISTAR MR - Registration 80136710130 - VAZ Syringe 60ml - AFFECTED LOTS: 0130214;...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.