BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTICHAMBER ADVANTAGE

    MDR report key: 2573805 · Received May 2, 2012

    Report

    Report Number
    2243193-2012-00002
    Event Type
    Other
    Date Received
    May 2, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 30, 2012
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K962822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT CLAIMS SPACER DID NOT WORK. CLAIMS SPACER DID NOT LET HER BREATHE IN. CLAIMS SHE WAS INSTRUCTED BY PHARMACIST ON HOW TO USE DEVICE AND SHE WAS STILL UNABLE TO GET MEDICATION. SHE STATES SHE DID NOT SEEK MEDICAL ATTENTION. HOWEVER SHE CLAIMS THAT HER LUNGS WERE HARMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other