BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEL MINI SINUS IMPLANT

    MDR report key: 4913328 · Received July 10, 2015

    Report

    Report Number
    3010101669-2015-00003
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPANY'S COMPLAINT INVESTIGATION, THE DEVICE WAS USED ACCORDING TO LABELED INDICATIONS. IN AN ABUNDANCE OF CAUTION, INTERSECT ENT IS REPORTING THIS EVENT AS A MALFUNCTION BASED ON THE INFORMATION IT RECEIVED AND THE REMOTE POSSIBILITY OF SERIOUS INJURY SHOULD A SIMILAR EVENT OCCUR.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT BILATERAL ENDOSCOPIC SINUS SURGERY WITH TURBINATE REDUCTION ALONG WITH SEPTOPLASTY IN WHICH DRUG ELUTING SINUS IMPLANTS WERE PLACED BILATERALLY IN THE ETHMOID SINUS POST-OPERATIVELY. 12 DAYS POST PLACEMENT, THE PATIENT PHONED THE PHYSICIAN TO REPORT THE IMPLANT ON THE RIGHT SIDE HAD MIGRATED TO HER THROAT WHEN SHE SNEEZED CAUSING HER TO GAG, A TEMPORARY SENSATION. THE PATIENT RETRIEVED THE IMPLANT WITH EASE BY REACHING INTO HER MOUTH/THROAT WITH HER HAND. THE PATIENT WAS REPORTED TO HAVE NO SUBSEQUENT ISSUES POST EVENT AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE SAME DAY, THE PATIENT WAS SEEN BY THE PHYSICIAN WHO DECIDED TO REMOVE THE LEFT SIDE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448591 PROPEL MINI SINUS IMPLANT OWO INTERSECT ENT 60011

    Patients

    Seq Age Sex Outcome Treatment
    1