Events

Avis De Sécurité sur Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet, Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet Palindrome SI Chronic Catheter Kit , Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet , Palindrome SI Chronic Catheter Kit

Selon Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Czechia qui a été fabriqué par Covidien LLC.

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
  • ID de l'événement
    45
  • Date
    2015-06-04
  • Pays de l'événement
    Czechia
  • Source de l'événement
    MHSIDCCCDMIS
  • URL de la source de l'événement
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alertes
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Notes supplémentaires dans les données

Device

Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet, Palindrome SI Chronic Catheter Kit w/VenaT...
  • Modèle / numéro de série
    Catalog Number: 8888145048 8888145048C 8888145048CP 8888145049 8888145049C 8888145049CP 8888145050 8888145050C 8888145050CP 8888145057 8888145057C 8888145057CP 8888145062 8888145063 8888145066 8888145066C
  • Description du dispositif
    Inactive implantable medical devices
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHSIDCCCDMIS