Events

Field Safety Notices about Ebb Complete Tamponade System (CTS-1000)

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Clinical Innovations, Inc. / Clinical Innovations Europe Ltd.

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
  • Event ID
    6.6.4-2015-59742
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Engangsprodukter--Ebb-Complete-Tamponade-System-CTS-1000--Clinical-Innovations-Inc--Clinical-Innovations-Europe-Ltd/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Extra notes in the data
    Ebb 08, Ebb 09
  • Action
    Products should be revoked. Affected lot number: 1214 V 424 and 1214 F-403. According to the manufacturer, there are potential risks of leakage during use. The reason that there can be leakage is a manufacturing defect in the attachment of the cuff / balloon. Leakage can cause serious injury due to non tamponadeffekt in the uterus. All affected products should be returned to the manufacturer. If you have any questions, MPA manufacturer or his representative.

Device

Ebb Complete Tamponade System (CTS-1000)

Manufacturer

Clinical Innovations, Inc. / Clinical Innovations Europe Ltd
  • Source
    SMPA