Events

Safety Alert for HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://portal.anvisa.gov.br/wps/wcm/connect/29ba32804c843d149d0edd93d95c4045/Lotes+Afetados+1171.pdf?MOD=AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1171
  • Date
    2012-08-28
  • 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
    Read the Letter to Customers carefully. Anvisa follows this action. http://en.wikipedia.org/w/index.php/
  • Reason
    Difficulty in firing the device, resulting in incomplete triggering and consequent incomplete stapling.
  • Action
    (1). Inspect your inventory immediately to verify that you have the affected product, and separate those products. (2). Fill out the Business Response Form and fax to INCLUDE LOCAL CONTACT, within 3 business days, even if you do not have the product affected. We request that you mention Event 7283. If you have any product to be returned, keep a copy of this form in your records. (3). To return the affected product, take a copy of the Business Response Form, place it in the box with your product, and attach the preprinted shipping label. (4). You are requested to share this information with all appropriate personnel in your facility. As with any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://po...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.