Events

Field Safety Notices about Vivano® Med Abdominal Kit

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by PAUL HARTMANN AG.

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
    2017-03-08
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    In our internal routine controls a deviation in the manufacturing process for the above mentioned organ protection layer has been identified. this could lead to a lower stability of the weld seams, which connects the application pockets to the pe organ protection layer. an increased mechanical load could lead to a potential risk that one of the applicator pockets could be detached. we have not received any reports of events related to this issue in connection with hartmann vivano® med abdominal kits at this time. .

Device

Vivano® Med Abdominal Kit

Manufacturer

PAUL HARTMANN AG