BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASOPORE

    MDR report key: 1601368 · Received February 12, 2010

    Report

    Report Number
    3004504732-2010-00001
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    July 24, 2009
    Report Date
    February 11, 2010
    Manufacturer
    POLYGANICS BV
    Product Code
    LYA
    PMA / PMN Number
    K052099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR INVESTIGATION, NOR WAS ADDITIONAL INFORMATION RECEIVED. IF FURTHER INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    INCIDENT OCCURRED AFTER 6 DAYS POSTOPERATIVE AFTER A PANSINUS OPERATION. A 4CM NASOPORE FORTE WAS PLACED INTO EACH MIDDLE MEATUS AND WET IT INTENSIVELY. THE 6TH DAY, THE PT DEVELOPED EYE LID AND CHEEK SWELLING AS WELL AS PAIN ON ONE SIDE WHILE THE OTHER SIDE WAS NOT PROBLEMATIC. AN ENDOSCOPIC INSPECTION OF THE MIDDLE MEATUS REVEALED A CAPSULATED UNDEFINITE CONGLOMERATE. THE MATERIAL WAS PERFORATED WITH A SUCTION DEVICE AND THE CONTENT WAS ASPIRATED. IMMEDIATELY AFTER THIS REMOVAL, THE PRESSURE AND DISCOMFORT WAS GONE. TWO WEEKS AFTER THIS NOTIFICATION, PT HAD TO BE RE-OPERATED BECAUSE HE DEVELOPED SUBSEQUENT PROBLEMS WITH A SYNECHIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASOPORE NASAL DRESSING LYA POLYGANICS BV

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention