URIDRAIN Male Urinary Control Device

  • Modèle / numéro de série
    Lot Numbers: 020272164 100370664
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
  • Description du dispositif
    URI-DRAIN Male Urinary Control Device - Large || Product ID: 8884732598 (sold in Canada only) || Intended use:Collector urine from male patients (and accessories) for indwelling catheter
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • Société-mère du fabricant (2017)
  • 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
    USFDA