BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEROGEL NASAL DRESSING & SINUS STENT

    MDR report key: 311083 · Received January 8, 2001

    Report

    Report Number
    1045254-2000-00023
    Event Type
    Injury
    Date Received
    January 8, 2001
    Date of Event
    January 1, 2000
    Report Date
    December 7, 2000
    Manufacturer
    FAB S.R.L.
    Product Code
    EPP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT BACK IN THREE DAYS AFTER SURGERY BECAUSE THE DOCTOR BELIEVES MEROGEL CAUSED INFECTION BY BLOCKING THE "NATURAL OSTEON".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739 MEROGEL NASAL DRESSING & SINUS STENT NASAL PACKING EPP FAB S.R.L. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention