BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU/O2 & AEROSOL/CATHETER

    MDR report key: 3712767 · Received March 25, 2014

    Report

    Report Number
    3005778470-2014-00011
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    BZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. ADDITIONAL PT/EVENT INFO WAS REQUESTED ON (B)(4) 2014. TO DATE NO ADDITIONAL INFO HAS BEEN RECEIVED. SHOULD ADDITIONAL PT/EVENT INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED CATHETER CAUSE IRRITATION AND SWELLING WITH ONE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175865 ICU/O2 & AEROSOL/CATHETER CATHETER, NASAL, OXYGEN BZB UNOMEDICAL S.R.O. 19017182 441639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention