BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN AND AEROSOL THERAPY

    MDR report key: 3998182 · Received July 10, 2014

    Report

    Report Number
    9680866-2014-00017
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT IS AS FOLLOWS: "LEAKAGE BETWEEN BAG AND PLASTIC PART (THE PART OF TAPE)". ADDITIONAL INFO REPORTED BASED ON THE PICTURE RECEIVED IS AS FOLLOWS: "AIR WAS LEAKING FROM THE TAPING WITH WHITE BAND BETWEEN BAG AND GRAY CONNECTING PART. ESPECIALLY THE LEAKAGE OCCUR THE PART WHICH I MARKED WITH BLACK CIRCLE ON THE ATTACHED PICTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405524 OXYGEN AND AEROSOL THERAPY MASK, OXYGEN BYG UNOMEDICAL S.A. DE C.V. 912MM 97863

    Patients

    Seq Age Sex Outcome Treatment
    1