BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL (MOMETASONE FUROATE IMPLANT 370 UG)

    MDR report key: 4117509 · Received September 19, 2014

    Report

    Report Number
    3010101669-2014-00005
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF INTERNAL RECORDS, THE COMPANY WAS NOT ABLE TO ESTABLISH A FAILURE TO MEET SPECIFICATION. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY IS SUBMITTING THE REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A (B)(6) YEAR OLD MALE WITH A HISTORY OF CHRONIC SINUS DISEASE AND ASTHMA UNDERWENT ENDOSCOPIC SINUS SURGERY AND TWO PROPEL SINUS IMPLANTS WERE PLACED BILATERALLY IN THE ETHMOID SINUSES. THE PT WAS PLACED ON ANTIBIOTICS FOR 10 DAYS POST OPERATIVELY. ON DAY ONE, POST-OP PACKING WAS REMOVED AND DAILY SALINE SINUS IRRIGATIONS WERE STARTED. ON (B)(6) 2014 (2 WEEKS POST-OP) THE PT COMPLAINED OF SIGNIFICANT HEADACHE, DECREASE IN VISUAL ACUITY, AND OCULAR PAIN. DURING THE 2 WEEK POST-OPERATIVE VISIT, THE PHYSICIAN OBSERVED BOTH PERI-ORBITAL AND LAMINA PAPYRACEA INFLAMMATION; HE OPTED TO REMOVE THE IMPLANTS AND PLACED THE PT ON ORAL STEROIDS. THE PT WAS REFERRED TO AN OPHTHALMOLOGIST, WHO DID NOT OBSERVED ANY OCULAR PATHOLOGY OR PRESCRIBED ANY ADDITIONAL MEDICATIONS. A CT SCAN WAS PERFORMED AND IT WAS REPORTED ON (B)(6) 2014, THAT THE SINUSES WERE CLEAR OF ANY SUBSEQUENT ISSUES. THE PT'S EYE SYMPTOMS HAD LESSENED, HOWEVER HE CONTINUED TO EXPERIENCE HEADACHES. THIS REPORT IS BASED ON INFO AVAILABLE TO THE COMPANY AT THE TIME THE REPORT WAS DUE FOR SUBMISSION AND MAY NOT REFLECT ALL INFO THAT MAY ULTIMATELY BECOME AVAILABLE THROUGH REQUESTS OR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583268 PROPEL (MOMETASONE FUROATE IMPLANT 370 UG) DRUG ELUTING SINUS STENT OWO INTERSECT ENT 70011 40520001

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention