Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MALLINCKRODT DO BRASIL LTDA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1117
  • Fecha
    2012-03-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    Sterilized packages of these devices were identified that were not sealed.
  • Acción
    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.