Events

Field Safety Notices about Inflator DOLPHIN

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 PEROUSE MEDICAL.

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
    2017-04-05
  • 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
    Some customers have notified perouse medical of a potential failure of the primary packaging (blister) of the dolphin inflatable device, which could compromise the sterility of the device. it is true that in some cases the blister shows clear, visible cracks that are always located in the same place (close to the holder or pressure gauge).

Device

Inflator DOLPHIN
  • Model / Serial
    1504XXXX do 1512XXXX 1601XXXX do 1612XXXX
  • Manufacturer
    PEROUSE MEDICAL

Manufacturer

PEROUSE MEDICAL