Events

Alerta De Seguridad para INTRASOUND UNITS BOOTS OF PAIN THERAPY; ALL UNITS 1999 AND 2000; THE FOLLOWING UNITS, MANUFACTURED IN 2001, ALREADY CORRUGATED HAVE LABELS WITH YELLOW OR RED ROUND STICKERS.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BOOTS THE CHEMISTS.

¿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
    25
  • Fecha
    2001-05-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The medical devices agency (uk) is advising that the adapter box of the unit's outlet can break and feel completely, expose the deprotected wires as a potential to cause electric shock a.
  • Acción
    THE ENGLISH AGENCY RECOMMENDS: (1) IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT WERE PURCHASED IN 1999 AND 2000 THAT MAY BE IN YOUR INVENTORY. (2) DISCONTINUE THE USE OF THE PRODUCTS AFFECTED IMMEDIATELY, TURN OFF THE ELECTRICITY SWITCH AND REMOVE THE ADAPTER FROM THE OUTLET. (3) RETURN THE PRODUCTS AFFECTED TO THE REPRESENTATIVE TO REPAIR, REPLACE OR REIMBURSEMENT. (4) REPORT USERS AND MAINTENANCE MANAGERS IN THE ESTABLISHMENT OF THE ALERT WITH THESE UNITS. HEALTH PROFESSIONALS WHO KNOW PATIENTS USING THESE EQUIPMENT MUST ALERT THEM FROM THE POTENTIAL PROBLEM AND GUIDE THEM TO TAKE THESE CORRECTIVE MEASURES.

Device

INTRASOUND UNITS BOOTS OF PAIN THERAPY; ALL UNITS 1999 AND 2000; THE FOLLOWING UNITS, MANUFACTURE...

Manufacturer

BOOTS THE CHEMISTS
  • Source
    ANVSANVISA