Events

Safety Alert for Mersilene

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Johnson & Johnson Gmbh, Alemania || Ethicon, Inc..

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
    I1608-351
  • Event Number
    2008DM-0001417
  • Date
    2016-08-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=126
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected that a group of product codes of the referenced device is being supplied with the incorrect user instructions insert (ifu), the product concerned is being delivered with the ifus for mersilene suture, where its indications are different, which could entail to potential confusion between users.

Device

Mersilene
  • Model / Serial
    RS20, RS21, RS22, RS23, D10117, D5789, D7164, D8014, D8062, D8113 and D9212, all batches without expiring.
  • Product Description
    It is indicated for the circular suture of the cervix. Ribbons without needles are used to separate or fix the tissues during surgical acts.
  • Manufacturer
    Johnson & Johnson Gmbh, Alemania || Ethicon, Inc.

Manufacturer

Johnson & Johnson Gmbh, Alemania || Ethicon, Inc.