Events

Safety Alert for Trade name: HEMOSTOP. Technical Name: Gingival Retractors and Hemostatic. ANVISA registration number: 10186370148. Risk class: II - Medium Risk. Affected batches: 1938021, 1938031, and 1962491

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dentsply Indústria e Comércio 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
    2041
  • Date
    2016-08-30
  • 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
    If the customer receives the wrong barcode product, he must inform Dentsply that the barcode product will be made. The following actions will be taken: - Rework of the customer tags that have bought more than 50 units of Hemostop with the wrong barcode. This rework will be done by our business advisor. - Send a letter of communication of data to customers who buy less than 50 units to verify if they need some rework units. If there are affected customers, the labels will be replaced in dental by our business advisor. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    The product hemostop, presented error in the labeling with the barcode changed. the exchange of the bar code of the product in question does not pose a risk to the population and does not give the product characteristics that are harmful to health. based on the description of the problem. it was concluded that the error can not cause health problems. however, some actions will be taken to minimize the error in the market without the need to withdraw the product on the market.
  • Action
    Field Action Code 3 triggered under the responsibility of the company Dentsply Indústria e Comércio Ltda. Company made correction in the field for exchange of labeling. Action Completed.

Device

Trade name: HEMOSTOP. Technical Name: Gingival Retractors and Hemostatic. ANVISA registration num...

Manufacturer

Dentsply Indústria e Comércio Ltda.