Events

Alerta De Seguridad para CLAVICULAR SUPPORT ALLOYS: (1) SELF-ADJUSTABLE, (2) II; (3) NEOPRENE KNEE SUPPORT; (4) PUNISHED KNEE SKULL; (5) BANDS / LEATHER LINES OF TENNIS "; (6) AMBIDEXTROUS, UNIVERSAL PULSE; (7) UNIVERSAL PÉLVICAS DRIVE BELTS; (8) UNIVERSAL; (9) 15 CM; (10) ELASTIC ANCHOR SUPPORT BANDS 7.5 CM; (11) UNIVERSAL ABDOMINAL BAND OF 25 CM. ALL PRODUCT CODES MANUFACTURED FROM SEPTEMBER 30, 1998 TO 4 DECEMBER 2000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DE ROYAL INDUSTRIES INC.

¿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
    14
  • 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
    BRAZIL - 08/14/2001. THE KNEE SUPPORT OF NEOPRENE IS A NATIONAL MANUFACTURING PRODUCT, MADE BY THE COMPANY SALVAPÉ PRODUTOS ORTOPÉDICOS LTDA. IT ALSO INFORMES THAT IT IS NOT AN IMPORTED PRODUCT OF THE "ROYAL" COMPANY.
  • Causa
    Not declared correct composition of the products: there is natural rubber that had not been declared. the manufacturer began a correction by letter of december 12, 2000.
  • Acción
    VERIFY THAT YOU HAVE RECEIVED THE DEROYAL LETTER OF DECEMBER 12, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. DEROYAL AFFIRMS THAT THE PRODUCTS MAY BE RETURNED FOR LABEL CORRECTION, OR USERS MAY REQUIRE THE NEW LABELS AND CORRESPOND IT ON THE PRODUCTS. FOR FURTHER INFORMATION CONTACT DEROYAL ON PHONE 0021-1-423-938-7828.

Device

CLAVICULAR SUPPORT ALLOYS: (1) SELF-ADJUSTABLE, (2) II; (3) NEOPRENE KNEE SUPPORT; (4) PUNISHED K...

Manufacturer

DE ROYAL INDUSTRIES INC
  • Source
    ANVSANVISA