Events

Field Safety Notices about AMS AdVance Male Sling System & AMS AdVance XP Male Sling System

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

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
    2014-07-28
  • Event Date Posted
    2014-12-08
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/12/08/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-implant-mrezica-za-musku-inkontinenciju-polipropilenski/
  • 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
    As a result of routine periodic product shelf life testing, ams has identified that the sterile barrier of some samples of packaging of the needle passer components supplied with the advance xp male sling system, may have potentially have breached and therefore not consistently meet the three year shelf life stated on the product label. further testing confirms that the packaging of the needle passers continues to meet the requirements for the only one year shelf life.

Device

AMS AdVance Male Sling System & AMS AdVance XP Male Sling System

Manufacturer

American Medical Systems
  • Source
    ALIMSA