BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHITOGEL ENDOSCOPIC SINUS KIT CSK-4

    MDR report key: 9511381 · Received December 20, 2019

    Report

    Report Number
    MW5091851
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 12, 2019
    Report Date
    December 13, 2019
    Manufacturer
    CHITOGEL LIMITED
    Product Code
    LYA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO AUTHOR YESTERDAY. SURGEON INSTRUCTED PT TO USE HYDROGEN PEROXIDE TO CLEAN NARES POST OPERATIVELY. SURGEON HAD IMPLANTED CHITOGEL INTRAOPERATIVELY. SURGEON FEELS THAT SCARRING OF MUCOSAL TISSUE WAS CAUSED BY A REACTION BETWEEN THE CHITOGEL AND PEROXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294933 CHITOGEL ENDOSCOPIC SINUS KIT CSK-4 SPLINT INTRANASAL SEPTAL LYA CHITOGEL LIMITED CSK-4 252212319K

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR