Events

Safety Alert for KYPHK HV-R HIGH VISCOSITY RADIOPHONE BODY - Registered in Anvisa under the number 80102510396 - Lots: EL21208; EL21708; EL24408; EL24608.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    999
  • Date
    2010-01-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company states that it has not received any complaints about this product. Anvisa has no record of adverse event reports or technical complaints regarding this product.
  • Reason
    The manufacturer of the kyphk hv-r radiophic high-vision bone cement product is conducting investigation of complaints regarding the characteristics of this product during its preparation. complaints include a longer time than necessary for cement to achieve adequate viscosity (mass state) and lack of consistency or homogeneity during preparation, as well as at the time of administration with the appropriate instrument (eg the device of cement introduction).
  • Action
    The company VR Medical Ltda (holder of the registration of the product in Brazil) has already begun issuing letters of notification to the customers who acquired the affected lots. The actions recommended to health professionals are as follows: (1) Check in your inventory the existence of affected products; (2) If a product is found, segregate it, identifying it properly so that it is not inadvertently used; (3) Communicate the company (see Source Description field) by means of a specific form; (4) Send the problem product (s) to VR Medical Ltda. If you work with this product but do not have the batches affected in your inventory, fill out the form anyway and send, stating that you do not have the batches affected.

Device

KYPHK HV-R HIGH VISCOSITY RADIOPHONE BODY - Registered in Anvisa under the number 80102510396 - L...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda
  • Source
    ANVSANVISA