Events

Safety Alert for Trade name: Curatec Polyurethane Foam. ANVISA registration number: 80246910014. Risk class: III. Affected model (s): 10 cm x 10 cm / 10 cm x 10 cm tracheostomy. Lot (s) / Serial Number (s) Affected: 16081604/16082001 "

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LM Farma Industria 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
    2046
  • Date
    2016-01-03
  • 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 the manufacturer: "It is important to note that no complaints or complaints have been filed in the market regarding this risk, so it is a voluntary and totally precautionary recall. the final customer, we kindly request that the collection of the above lots be done also with your customers. The return of the product must be made to LM Farma by invoice of return. our Customer Service Department. "
  • Reason
    The company lm farma, during the process of validation of a new envelope size, through the methylene blue dye test performed exclusively in validations, evidenced the formation of microchannels at the point of intersection between the supplier's seal (amcor) and the sealing performed internally by the company lm farma. non-compliance number 155/16 was opened and during the batch investigation it was found that the packaging material in use is subject to interference by small processing variations in each sealing equipment (time, pressure, temperature, rubber and sealing bar, alignment of the beat between the cheeks, weight and type of material used), until then categorized in the same group.
  • Action
    Field action classification: Pickup, Return to manufacturer. Field action code: AC006 / 16. Recommendations to users and patients: Risks to the patient: The sealing of the envelope forms a barrier to preserve the sterility of the product. The use of a non-sterile product could expose more debilitated patients to the risk of infection. Necessary measures: Do not use the product with suspected quality deviations; Inform available stock for LM Farma to expedite the replacement of products to be collected

Device

Trade name: Curatec Polyurethane Foam. ANVISA registration number: 80246910014. Risk class: III. ...

Manufacturer

LM Farma Industria e Comércio Ltda