Events

Alerta De Seguridad para WARMING MITTS AND SEALS: (1) HYPOTHERMAL RESCUE (THERMAL RESCUE HYPOTHERMIA), (2) THERMO-STAT HYPOTHERMIA (THERMO-STAT HYPOTHERMIA). WE. CATALOG: (1) TR 04004 / ETR-04004, 06-003 / 1T0311; (2) 10-1005 / 1T0310; ALL LOT NUMBERS

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

¿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
    160
  • Fecha
    2000-04-12
  • 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
    Water may evaporate from polyvinyl chloride bag on the heating gloves mentioned after long storage periods. this evaporation results in an increase in salt concentrations, which could increase the temperature of the sleeve and cause burns in the patient. aquarius medical has not received any complaint or report of injury caused by use of the above gloves mentioned. the manufacturer started a removal by correspondence dated 12 april 2000.
  • Acción
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 12 APRIL 2000 AND THE AQUARIUS MEDICAL PRODUCTION INFORMATION FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DISCLAIMS THE USE AND DISTRIBUTION OF ANY DEFECTIVE PRODUCT, CONSIDER IT TO BE USED AND DESTRUCTES IT IN ACCORDANCE WITH APPLICABLE LAWS, REGULATIONS AND DECREES, FEDERAL, STATE AND LOCAL. PLEASE FILL OUT THE PRODUCTION INFORMATION FORM AND SEND TO AQUARIUS MEDICAL BY MAIL AT THE ABOVE ADDRESS OR BY FAX AT 1 (480) 991-4335. IF YOU PREFER TO RETURN THE DEFECTIVE PRODUCT, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH AQUARIUS MEDICAL BY PHONE 1 (480) 991-1818 TO RETURNED GOODS AUTHORIZATION NUMBER. FOR FURTHER INFORMATION, PLEASE CONTACT CHRISTINA FLEMING, AQUARIUS MEDICAL, BY PHONE1 (480) 991-1818, RAMAL 219.

Device

WARMING MITTS AND SEALS: (1) HYPOTHERMAL RESCUE (THERMAL RESCUE HYPOTHERMIA), (2) THERMO-STAT HYP...

Manufacturer

AQUARIUS MEDICAL CORP
  • Source
    ANVSANVISA