Events

Safety Alert for Male condoms "H" - registration 80325300002 - Lots: PM1005; PM1305 and PM1705.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PH ENGENHARIA 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
    1096
  • Date
    2011-10-18
  • 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 DRC 62 of September 3, 2008, male condoms for natural rubber latex must also meet the requirements for certification of compliance under the Brazilian System for Conformity Assessment (SBAC). #### UPDATE - 07/11/2011 - The affected lots included in this alert have been incinerated, according to Attached Certificate, in accordance with current legislation. The company will undergo a new inspection and testing for Certification. ####
  • Reason
    Failure in the counter-test tests as evidenced by test reports no. 212.151 / 1/2/3/11, in the possession of the certifying body.
  • Action
    Check for the existence of the affected product in your inventories and segregate them for recall from the manufacturer, record holder.

Device

Male condoms "H" - registration 80325300002 - Lots: PM1005; PM1305 and PM1705.

Manufacturer

PH ENGENHARIA INDÚSTRIA E COMÉRCIO LTDA.
  • Source
    ANVSANVISA