Events

Safety Alert for NITINOL GUIDE FOR CATETER URODRAIN PROMEDON Technical Name: Catheter Introductory Guide ANVISA Registration Number: 10306840122 Hazard Class: II Affected Model: G-35-150S-NIT Serial Numbers Affected: Code: G-35- 150S-NIT Lots: 30892 to 30901; 31103 to 31106; 31109 to 31110; 31113 to 31115; 31430 to 31442; 31484; 31777 to 31789; 31907; 32138; 32139 to 32144; 32147; 32306 to 32311; 32614 to 32619 and 32680.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES; Promedon S.A..

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
    2316
  • Date
    2017-06-19
  • 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
    Return of items in stock. Update of the field action: UPDATED ON 10/2/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    It was identified that there was a decrease in the hydrophilic property of the product by exposure to temperatures outside the specification during the import process.
  • Action
    Field Action Code # 01-2017 triggered under the responsibility of the company PROMEDON DO BRASIL MEDICAL HOSPITAL PRODUCTS. Company will collect for further destruction.

Device

NITINOL GUIDE FOR CATETER URODRAIN PROMEDON Technical Name: Catheter Introductory Guide ANVISA Re...

Manufacturer

PROMEDON DO BRASIL PRODUTOS MEDICO HOSPITALARES; Promedon S.A.