BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTICHAMBER VALVED HOLDING CHAMBER

    MDR report key: 2093574 · Received April 15, 2011

    Report

    Report Number
    2243193-2011-00003
    Event Type
    Other
    Date Received
    April 15, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K962822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE IS VERY COMMON AND INERT MATERIAL FOR VALVED HOLDING CHAMBER MASKS. THERE IS A POSSIBILITY THAT THE CHILD WAS HAVING AN ALLERGY TO THE DRUG AS THERE WAS NO MALFUNCTION OF THE DEVICE NOR SIMILAR COMPLAINTS. THE MASK MATERIAL WAS TESTED FOR SKIN IRRITATION AND WAS SPECIFICALLY CHOSEN FOR ITS INERT PROPERTIES.

    Description of Event or Problem · 1

    MOTHER DESCRIBES THAT CHILD HAS A RASH IN THE AREA OF THE PEDIATRIC MASK USED WITH THE OPTICHAMBER VALVED HOLDING CHAMBER. THE MASK IS MADE OF SILICONE AND HAS BEEN TESTED FOR BIOCOMPATIBILITY. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE AND IT IS POSSIBLE THAT THE MASK IS NOT THE CAUSE OF THE RASH AND THAT THE ROOT CAUSE MAY BE THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICHAMBER VALVED HOLDING CHAMBER VALVED HOLDING CHAMBER CAF RESPIRONICS NEW JERSEY, INC. HS80010

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other