Events

Field Safety Notices about Sinaqua Dermal Glove, Sinaqua Wipe as well as Easyderm Glove

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 WELCARE INDUSTRIES S.p.A..

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
    2016-07-25
  • 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
    We have become aware that a custom-made version of sinaqua dermal glove , produced for another country, has been contaminated with burkholderia cepacia. as a precaution, we are withdrawing all the lots of sinaqua dermal glove as well as sinaqua wipe and easyderm glove . the lot numbers are indicated above. potential risk sinaqua dermal glove is a class i, non sterile, premoistened glove for cleansing intact skin. should the device be contaminated with burkholderia cepacia, the bacteria poses no/ little medical risk to healthy people. however, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to respiratory infections, keeping in mind that the effects of b. cepacia vary widely.

Device

Sinaqua Dermal Glove, Sinaqua Wipe as well as Easyderm Glove

Manufacturer

WELCARE INDUSTRIES S.p.A.