Events

Avis De Sécurité sur Sinaqua Dermal Glove, Sinaqua Wipe as well as Easyderm Glove

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par WELCARE INDUSTRIES S.p.A..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-07-25
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.