Events

Field Safety Notices about Polylactin 910

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Demetech Corp..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2011-02-13
  • Event Date Posted
    2012-02-27
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/02/27/povlacenje-medicinskog-sredstva-aptus/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The health worker stated in his report that at 3 threads, while removing the surgical thread from the package, there was a separation of the needle from the thread and spontaneous tearing of the thread into parts. in the second case, on the same day, during the first passage of the thread through the tissue of the abdomen, and during the operation, the needle was separated from the rest of the thread, and when removing the rest of the thread from the wound, the thread broke.

Device

Polylactin 910

Manufacturer

Demetech Corp.