Events

Alerta De Seguridad para POLYBONE ORIGINAL (registration 10355870054) Technical name: BONES AND ASSOCIATED DEVICES / ORTHOPEDIC CEMENT, WITHOUT MEDICINE ANVISA registration number: 10355870030 Hazard class: IV Affected model: PBBG205 (registration 10355870030) ) / PBO-5 and PBO-10 (registration 10355870054) Affected serial numbers: PBBG205 - Batch: P2110081; PBBG205 - Batch: P2110097; PBBG205 - Batch: P2120036; PBBG205 - Batch: P2120038; PBBG205 - Lot: P2140011; PBBG205 - Batch: P2140036; PBBG205 - Batch: P2150024; PBBG205 - Batch: P2150029; PBBG205 - Batch: P2150031; PBBG205 - Lot: P2150033; PBBG205 - Lot: P2160005; PBBG205 - Lot: P2160015; PBO-5 - Lot: P02110047; PBO-5 - Lot: P2150005; PBO-10 - Lot: P2110096; PBO-10 - Lot: P2130049; PBO-10 - Lot: P2140040; PBO-10 - Lot: P2150001; PBO-10 - Lot: P2150010; PBO-10 - Lot: P2150018; PBO-10 - Lot: P2150020; PBO-10 - Lot: P2150028; PBO-10 - Lot: P2150030; PBO-10 - Lot: P2150032.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomédica Equipamentos e Suprimentos Hospitalares Ltda.; Kyungwon Medical Co., Ltd..

¿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
    2266
  • Fecha
    2017-04-12
  • 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
    It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the affected products to the manufacturer. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.
  • Causa
    Resolution re no. 918 of april 4, 2017 was published in the official gazette of the federal government of 04/10/2017 (no. 69, section 1, page 47), in which the national health surveillance agency ) determines the suspension of the importation, distribution, marketing and use of polybone original and polybone products, considering the completion of the international inspection report unsatisfactory for kyungwon medical co., ltd and that most of the nonconformities found in the report are directly related with the products manufactured.
  • Acción
    Field Action Code 4 triggered under the responsibility of the company BIOMÉDICA EQUIPAMENTOS E SUPRIMENTOS HOSPITALARES LTDA. Company will make collection for later return to the manufacturer.

Device

POLYBONE ORIGINAL (registration 10355870054) Technical name: BONES AND ASSOCIATED DEVICES / ORTHO...

Manufacturer

Biomédica Equipamentos e Suprimentos Hospitalares Ltda.; Kyungwon Medical Co., Ltd.
  • Source
    ANVSANVISA