Events

Field Safety Notices about INCISE DRAPE 56X80

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Medos Molnlycke Health Care AB.

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
    2016-06-21
  • Event Date Posted
    2013-01-08
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/08/01/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-incise-drape-56x80-hirurska-prekrivka/
  • 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
    Our molnlycke health care, incise drape products, manufactured in the 12151579 series and 12391638, have a seal defect on the outer package, causing an incomplete or open seal; like result, the sterility of the product within the packaging is compromised.

Device

INCISE DRAPE 56X80

Manufacturer

Medos Molnlycke Health Care AB