BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEROGEL NASAL DRESSING & SINUS STENT 2/BX

    MDR report key: 309116 · Received December 20, 2000

    Report

    Report Number
    1045254-2000-00022
    Event Type
    Injury
    Date Received
    December 20, 2000
    Date of Event
    October 2, 2000
    Report Date
    November 2, 2000
    Manufacturer
    FAB S.R.L.
    Product Code
    EPP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED: MEROGEL CAUSED SEVERE TISSUE REACTION TO PT. PT RETURNED TO OR-REACTIVE POLYPOID TISSUE DEBRIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEROGEL NASAL DRESSING & SINUS STENT 2/BX NASAL PACKING EPP FAB S.R.L. * 011110

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention