BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER & PAYKEL FLEX FIT NASAL MASK

    MDR report key: 2102313 · Received May 20, 2011

    Report

    Report Number
    MW5020687
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    May 10, 2011
    Manufacturer
    FISHER & PAYKEL
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER WEARING THE MASK FOR SEVERAL MONTHS, MY EYES DEVELOPED DRY EYE. I WENT TO THE EYE DR AND THAT IS WHAT HE SAID I HAD TO USE EYE DROPS. I HAVE TALKED TO MY EYE DR ABOUT THESE MASK IN (B)(6) AND ON (B)(6) 2011 I TALKED TO THE EYE DR AT (B)(6) - THEY BOTH SAID THE SAME THING ABOUT MASKS CAUSING LOTS OF TROUBLE FOR PT'S EYES. I SLEPT WITH THE MASK FOR SEVERAL MONTHS AND REALIZED SOMETHING WAS WRONG - SO BOUGHT A DIFFERENT MASK. I FEEL THE VENTS ON THE MASK ARE SITUATED AND BLOW IN YOUR EYES WHILE YOU ARE SLEEPING. I HAVE TALKED TO THE COMPANY AND HAVE SENT THEM LETTERS, BUT REFUSE TO BELIEVE WHAT I AM SAYING ALTHOUGH INITIALLY THE PERSON TOLD ME TO GET ALL OF MY VISITS 5 (NOW 6) AND THE EYE DR WHICH I DID. MY EYES ARE A LITTLE BETTER, BUT STILL USE THE EYE DROPS. DATES OF USE: 2008- 2009. DIAGNOSIS: SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER & PAYKEL FLEX FIT NASAL MASK NASAL MASK FOR CPAP MACHINE FOR SLEEP APNEA BZD FISHER & PAYKEL FLEX FIT 406 0801018

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R APNEA EACH NIGHT| FLEX FIT NASAL MASK FOR CPAP MACHINE FOR SLEEP