BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL (MOMETASONE FUROTE IMPLANT 370 UG)

    MDR report key: 3987593 · Received July 25, 2014

    Report

    Report Number
    3010101669-2014-00003
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 25, 2014
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPANY'S COMPLAINT INVESTIGATION, THE DEVICE MET ITS SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A (B)(6) PT UNDERWENT ENDOSCOPIC SINUS SURGERY WITH ETHMOIDECTOMY AND A PROPEL SINUS IMPLANT WAS PLACED IN THE RIGHT ETHMOID SINUS. THE PT WAS PLACED ON AN ANTIBIOTIC REGIMEN AND DAILY NEILMED SINUS RINSE IRRIGATIONS STARTING DAY ONE AFTER HIS PROCEDURE. ON (B)(6) 2014 THE PHYSICIAN NOTED A SUPERFICIAL FUNGAL INFECTION IN THE RIGHT ETHMOID SINUS DURING FOLLOW UP. THE PT COMPLAINED OF SEVER PAIN DURING DEBRIDEMENT IN THE OPERATING ROOM UNDER ANESTHESIA AND REMOVED THE IMPLANT. THE PT WAS DISCHARGED WITH ANTIBIOTICS AND ANTI-FUNGAL THERAPY. ON (B)(6) 2014 PHYSICIAN REPORTED THE FUNGAL INFECTION HAD FULLY RESOLVED AND THERE WAS NO SIGN OF CHRONIC INFECTION, AND THE SINUS WAS HEALING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436979 PROPEL (MOMETASONE FUROTE IMPLANT 370 UG) DRUG ELUTING SINUS STENT OWO INTERSECT ENT 70011 40325001

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention