BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVENT SLEEP APNEA THERAPY

    MDR report key: 6128964 · Received November 23, 2016

    Report

    Report Number
    MW5066350
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 23, 2016
    Manufacturer
    PROVENT SLEEP THERAPY
    Product Code
    OHP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROVENT WAS DEFECTIVE. THE MESH CAME UNGLUED FROM THE BACKING ON BOTH NOSTRILS DURING THE NIGHT, SO THE DEVICE DID NOT WORK. ALL RESISTANCE TO BREATHING WAS LOST, LEADING TO APNEIC EPISODES AND FATIGUE THE FOLLOWING DAY. THIS HAS HAPPENED A FEW TIMES IN RECENT WEEKS. ANOTHER PROBLEM IS THAT THE PRODUCT DOESN'T STICK WELL TO THE SKIN, EVEN AFTER THOROUGHLY WASHING THE SKIN AND REMOVING ALL OIL WITH AN ALCOHOL WIPE. I NOW PUT PAPER TAPE AROUND ALL OF THE EDGES SO IT STICKS TO MY SKIN, AND THEN IT WORKS VERY WELL (EXCEPT WHEN IT MALFUNCTIONS, AS DESCRIBED ABOVE). THE COMPANY SHOULD EITHER MAKE THE PRODUCT STICK BETTER TO THE PATIENT'S SKIN OR RECOMMEND THAT PAPER TAPE BE USED TO MAKE IT STICK BETTER. BECAUSE SLEEP APNEA GREATLY INCREASES MORBIDITY AND MORTALITY, I WOULD ANTICIPATE THAT THIS WOULD SAVE A LOT OF LIVES. HAVING SAID THIS, IT'S A GREAT PRODUCT FOR THE MILLIONS OF PEOPLE WHO CAN'T USE CPAP (I COULD TOLERATE IT BUT COULDN'T FIND A MASK THAT FIT MY FACE), AS LONG AS YOU PUT PAPER TAPE AROUND THE EDGES. MY AHI WENT DOWN TO CLOSE TO 0 WITH TAPE, WHEREAS IN THE PACKING INSERT (WITHOUT USING PAPER TAPE) IT'S PRETTY HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775849 PROVENT SLEEP APNEA THERAPY PROVENT SLEEP APNEA THERAPY OHP PROVENT SLEEP THERAPY 34389

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ALLEGRA| ALREX| ASA| CO-ENZYME Q| CO-ENZYME Q| CRESTOR| ETHACRYNIC ACID| LOSARTAN| LUNESTA| MVI| OTC MEDS: PROBIOTICS| QNASL| RANITIDINE| RESTASIS| RX MEDS: SYNTHROID| ZYRTEC