BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OX.CAN. 10/210/74 MM

    MDR report key: 5209918 · Received November 9, 2015

    Report

    Report Number
    3007966929-2015-31242
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    December 22, 2011
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    CAT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    COMPLAINANT REPORTS "WHEN INSTALLING AN EXTRACTOR OF OXYGEN IN THE HOME OF A PATIENT, THE TECHNICIAN FINDS THAT THE NASAL CANULA WERE BLOCKED. THEY REMOVED THE LOT AND INFORMED PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740846 OX.CAN. 10/210/74 MM CANNULA, NASAL, OXYGEN CAT UNOMEDICAL LTD. 29001490 640875

    Patients

    Seq Age Sex Outcome Treatment
    1