Events

Safety Alert for Trade name: VIVANOMED ABDOMINAL KIT Technical name: HEALING Registration number ANVISA: 80170310073 Hazard class: III Model affected: VIVANOMED ABDOMINAL KIT; VIVANOMED ABDOMINAL; VIVANOMED FOAM; HYDROFILM; VIVANOTEC PORT; PLASTIC TRAY Serial numbers affected: REF 409720 lots: 500228119; 500443116; 600216115; 600102111. REF 409721 lots: 400207115; 400316114; 500130115; 500238118.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Bace comércio Internacional ltda.; Paul Hartmann AG.

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
    2232
  • Date
    2017-03-17
  • 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
    The recall is occurring voluntarily by the manufacturer of the product. Do not use the product, segregate it and contact registration holder (Bace Comercio Internacional ltda) by telephone (11 3168-0226) or via email (recall@bace.com.br) to schedule a return and exchange of the product.
  • Reason
    Vivano® med abdominal kits are sets of dressings for the treatment of negative pressure wounds in conjunction with a vivano® tec negative pressure therapy system. these kits include in addition to the hydrophobic pu (polyurethane) foam dressing, a protective layer of pe (polyethylene) organ. the organ protection layer is a round micro perforated polyethylene film (ø 65 cm) with 6 welded application pockets, designed to facilitate the introduction of this layer of organ protection between the abdominal wall and internal organs. a deviation in the manufacturing process of the above-mentioned organ protection layer has been identified in our internal routine controls. this can lead to reduced stability of the solder joints, which connect the application pockets to the protective layer of pe organs. high mechanical load can lead to the risk of one of the pockets of the applicator detaching.
  • Action
    Field Action Code BACE01 triggered under the responsibility of the company BACE COMÉRCIO INTERNACIONAL LTDA. Company will collect.

Device

Trade name: VIVANOMED ABDOMINAL KIT Technical name: HEALING Registration number ANVISA: 801703100...

Manufacturer

Bace comércio Internacional ltda.; Paul Hartmann AG
  • Source
    ANVSANVISA