BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN AND AEROSOL THERAPY

    MDR report key: 3971252 · Received July 9, 2014

    Report

    Report Number
    9680866-2014-00009
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A SERIOUS INJURY. THE DEVICE WAS USED ON A PATIENT, HOWEVER THERE WAS NO REPORT OF HARM TO THE PATIENT. THE END USER WAS GIVEN A NEW NON-RE-BREATHER MASK AND WAS ABLE TO COMPLETE THE PROGRAM. THE END USER WAS SENT TO THE CLINIC BECAUSE SHE FELT SHORT OF BREATH PRE-EXERCISE AND WAS UNSURE IF ISSUES STARTED AT HOME WITH MASK OR OTHER ISSUES, BUT NO PRESCRIPTION WAS REQUIRED. IT WAS REPORTED THAT THE PATIENTS' HEIGHT AND WEIGHT WOULD BE DIFFICULT FOR THEM TO OBTAIN. FURTHERMORE, THEY DON'T EXACTLY HOW LONG THE MASK WAS BEING USED ON PATIENTS, BUT IT WAS A VERY SHORT TIME AS THEY HAVE ONLY BEEN USING THE MASKS FOR A FEW WEEKS. AN INITIAL QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. THE COMPLAINT SAMPLE HAS BEEN REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING EVALUATED. THIS IS THE FIRST COMPLAINT OF THIS TYPE RECEIVED FOR THIS PRODUCT. NO PREVIOUS INVESTIGATION EXISTS FOR THIS ISSUE FOR THIS PRODUCT. BASED ON THIS REVIEW UNABLE TO DETERMINE IF PRODUCT MEETS SPECIFICATION. AN INVESTIGATION IS REQUIRED TO DETERMINE IF ANY FURTHER ACTIONS ARE REQUIRED. THIS INVOLVES FIVE PATIENTS WITH FOUR DIFFERENT ISSUES; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (6) CASES. NOTE: THE ACTUAL DATE OF EVENT (B3) IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JULY 08, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BAG INFLATED, BUT DID NOT DELIVER THE APPROPRIATE OXYGEN. THE END USER WAS ON 15 LITERS NON-RE-BREATHER MASK AND DESATURATION BEGAN WITH MINIMUM EXERCISE, FROM STRETCHING TO OXYGEN LEVEL WHEN DOWN TO 80% AND ON THE THEN ON A BIKE IN LESS THAN 2 MINUTES TO IT WENT DOWN TO 84%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400648 OXYGEN AND AEROSOL THERAPY MASK, OXYGEN, NON-REBREATHING BYG UNOMEDICAL S.A. DE C.V. 106-E CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention