BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVENT PROFESSIONAL SLEEP APNEA THERAPY

    MDR report key: 2810047 · Received October 24, 2012

    Report

    Report Number
    3007038487-2012-00001
    Event Type
    Injury
    Date Received
    October 24, 2012
    Manufacturer
    VENTUS MEDICAL
    Product Code
    OHP
    PMA / PMN Number
    K102404
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP WAS CONDUCTED BY VENTUS MEDICAL WITH THE PATIENT'S EYE DOCTOR, DR. (B)(6) ON (B)(6) 2012. PER DR. (B)(6), PATIENTS WHO HAVE HAD TEAR DUCT SURGERY AND WHO HAVE A "TWO-WAY" TEAR DUCT, THE USE OF ANY POSITIVE PRESSURE DEVICE IN THE AIRWAY WILL RESULT IN AIR VENTING INTO THE EYE. THIS DRIES THE EYE OUT AND MAKES IT SUSCEPTIBLE TO SCRATCHES AND TEARS. DR. (B)(6) REPORTS RECOMMENDING THAT THE PATIENT USE EYE DROPS WHEN USING PROVENT: DR. (B)(4), WAS CONSULTED ON THIS ISSUE ON (B)(4) 2012. HE STATED THAT: " I HAVE REVIEWED THE MATERIAL YOU SENT. I AM NOT AWARE OF ANY REPORTS OF EYE COMPLICATIONS FROM NASAL POSITIVE AIRWAY PRESSURE ABSENT CPAP MASK LEAKS ALLOWING AIR TO BE BLOWN ONTO THE EYES. HOWEVER, IF THE VALVE (THE VALVE OF HASNER OF THE PLICA LACRIMALIS) WHICH CLOSES OFF THE NASAL CAVITY FROM THE NASOLACRIMAL DUCT WAS REMOVED OR MADE INOPERABLE BY SURGERY, THEN AIR UNDER PRESSURE COULD ESCAPE THROUGH THE PUNCTA INTO THE INNER CORNER OF THE EYE, POTENTIALLY LEADING TO DRY EYES. A BRIEF LITERATURE SEARCH DID NOT TURN UP ANY REFERENCES TO THIS POTENTIAL PROBLEM WITH CPAP, NOR IS IT MENTIONED IN THE LATEST EDITION OF "PRINCIPLES AND PRACTICE OF SLEEP MEDICINE." THERE WERE NO EYE-RELATED COMPLAINTS REPORTED PREVIOUSLY BOTH OVERALL FOR THE PRODUCT AND SPECIFICALLY FOR THIS LOT NUMBER. THIS APPEARS TO BE AN ISOLATED INCIDENT. THE TEAM IS THEREFORE GONG TO MONITOR FOR TRENDS FOR THIS ISSUE GOING FORWARD.

    Description of Event or Problem · 1

    THE PATIENT REPORTED GETTING A "GOOD NIGHT'S SLEEP" WITH PROVENT. AFTER THE FIFTH NIGHT OF USE, SHE WOKE UP WITH BLURRY VISION. THE DEVICE HAD REMAINED ON HER NOSE ALL NIGHT ON THE FIFTH NIGHT AND SHE REMOVED THEM IN THE MORNING, WHICH WAS WHEN SHE NOTICED THE CHANGES IN HER VISION. SHE WENT TO HER EYE DOCTOR IMMEDIATELY. HER EYE DOCTOR OBSERVED SCRATCHES ON HER RIGHT CORNEA AND HE GAVE HER EYE DROPS TO HELP HEAL THE SCRATCHES. SHE BELIEVES THE SCRATCHES WERE RELATED TO THE PRESSURE CREATED BY PROVENT THERAPY. THE SCRATCHED SURFACE AND THE BLURRINESS IN THE PATIENT'S VISION RESOLVED AFTER 2-3 HOURS THAT DAY. THE PATIENT WENT BACK TO THE DOCTOR 2-3 DAYS LATER, COMPLETED A VISION TEST AND SHE REPORTED THAT HER VISION TEST FROM TWO WEEKS PRIOR, WHEN SHE HAD VISITED HIM FOR AN UNRELATED CHECKUP). SHE REPORTED THAT THE DOCTOR SAID THAT THE SCRATCHES HAD RESOLVED BUT THAT HE SUSPECTED AN INFECTION, AND PUT HER ON MEDICATION. SHE THEN RETURNED TO HIM 2 WEEKS LATER AND, DURING THIS VISIT, HE COMPLETED ANOTHER VISION TEST WITH STILL NO IMPROVEMENT. SHE HAS SINCE HAD SURGERY TO CORRECT HER TEAR DUCT. SHE IS NOW ABLE TO USE CPAP MACHINE AGAIN (WITH NASAL PILLOWS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVENT PROFESSIONAL SLEEP APNEA THERAPY PROVENT THERAPY OHP VENTUS MEDICAL 31325

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR