BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEIL MED SINUGATOR

    MDR report key: 7510644 · Received May 11, 2018

    Report

    Report Number
    MW5077177
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    May 6, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NEILMED PHARMACEUTICALS, INC.
    Product Code
    KMA
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEILMED SINUGATOR CAUSED A DURA TEAR. CEREBROSPINAL FLUID IS LEAKING FROM THE BRAIN. MAY REQUIRE SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348252 NEIL MED SINUGATOR IRRIGATOR POWERED NASAL KMA NEILMED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L