Events

Safety Alert for Cardiac Monitoring Electrode - Model 2223BR. Anvisa Registry: 80284930186. Lots affected in Brazil: 0818200376; 0818400251; 0820700723; 0820900183; 0821000474; 0821100554; 0821200380.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 3M do Brasil 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
    944
  • Date
    2008-10-19
  • 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
    According to 3M do Brasil Ltda, the level of risk associated with the event is considered low, since the occurrence is low (occasional) and the probability of serious adverse health consequences is practically non-existent - due to the easy identification by the professional who is using the product, to notice any change in the monitoring signal. The problem was caused by a deviation in the production equipment and occurred in the periods of 01 to 03/07/2008 and 28 to 31/07/2008. According to the Regulatory Affairs Department of 3M do Brasil Ltda, the company has not yet received reports of related adverse events. The forecast for completion of the collection is 3 months.
  • Reason
    The product registration holder (3m do brasil ltda.) has verified that, on some electrodes of the lots mentioned, the pin and cotter pin insertion can be easily released.
  • Action
    According to information submitted to the Anvisa Technological Monitoring Unit (UTVIG / ANVISA), to date the actions of the registry holder to solve the problem were as follows: (1) Implementation of in-process tests and quality control to assess the fit of the pins and contrapinos with determined frequencies and to each adjustment of machine (action already implemented); (2) Risk Analysis of the problem, with the objective of evaluating the impact on the client's health, product quality; (3) Identification of customers who purchased the lots in question; (4) Notice on the payment to customers who purchased the lots in question; (5) Contact with Technovigilance to publicize voluntary collection. To the users and distributors of the products mentioned in this alert, the following actions are recommended: (1) To segregate in its establishment any remaining amount of product of the batches in question; (2) Identify the products at risk found, so that there is no inadvertent use; (3M do Brasil Ltda. / Rodovia Anhanguera, Km 110, Sumaré - SP / Contact: Érika Silva (esilva@mmm.com) / Cristiane Franco (2) Please contact 3M to let us know if you have purchased one of the lots (registries3m@mmm.com) Tel .: 0800-153131).

Device

Cardiac Monitoring Electrode - Model 2223BR. Anvisa Registry: 80284930186. Lots affected in Brazi...

Manufacturer

3M do Brasil Ltda.
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    ANVSANVISA