BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEROCEL NASAL DRESSING AND SINUS STENT

    MDR report key: 270947 · Received March 22, 2000

    Report

    Report Number
    1045254-2000-00004
    Event Type
    Injury
    Date Received
    March 22, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 29, 2000
    Manufacturer
    FAB S.R.L.
    Product Code
    EMX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATES: "DR PERFORMED ETHMOIDECTOMY AND PACKED NOSE POST-OP WITH MEROCEL (SPONGE). REMOVED MEROCEL (SPONGE) AFTER ONE WEEK. DR NOTICED ADHESIONS AFTER THREE WEEKS THEN PLACED MEROCEL IN NOSE. THIRTY-SIX HRS LATER PT HAD THE BEGINNINGS OF A TOXIC SHOCK SYNDROME. MEROCEL WAS REMOVED AND ANTIBIOTIC THERAPY BEGAN. DR BELIEVES MEROCEL CAUSES A PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEROCEL NASAL DRESSING AND SINUS STENT NASAL PACKING EMX FAB S.R.L. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R