Events

Safety Alert for Silicone pessaries / Gynecological pessary

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Coopersurgical 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
    R1705-157
  • Event Number
    2015DM-0014123
  • Date
    2017-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 informs that the secondary packaging box of the referenced devices is marked as latex free product, generating a high risk of a severe allergic reaction for the users allergic to latex, leading to potential adverse events on the patients.

Device

Silicone pessaries / Gynecological pessary
  • Model / Serial
  • Product Description
    Unless otherwise specified in the instructions, it is recommended that the placement be performed by medical personnel. Uses: pespesarios are used as support for certain pelvic organs that have suffered prolapse in order to reposition them in their original location. Some pessaries are specifically designed to stabilize the urethra in cases of stress urinary incontinence (loss of urine when coughing, laughing or intense exercise, certain types of pessary require the patient to remove it at night or when the patient has sex.
  • Manufacturer
    Coopersurgical Inc

Manufacturer

Coopersurgical Inc