BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASHIELD®

    MDR report key: 4596480 · Received March 12, 2015

    Report

    Report Number
    1045254-2015-00078
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    January 21, 2015
    Report Date
    February 18, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LYA
    PMA / PMN Number
    K141704
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE: (B)(6). PATIENT WEIGHT: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NOVASHIELD INJECTABLE NASAL PACKING WAS USED FOR A BILATERAL FRONTOSPHENOETHMOIDECTOMIES WITH ANTROSTOMIES. THE PHYSICIAN REPORTED THAT TWO WEEKS AFTER THE FESS PROCEDURE, THE PATIENT EXPERIENCED SYNECHIA (ADHESION(S)) AS WELL AS POOR DRAINAGE. THE PATIENT WAS PRESCRIBED SALINE IRRIGATION AND WAS COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS. FOLLOW-UP WITH THE PHYSICIAN INDICATES THAT THE PATIENT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171179 NOVASHIELD® SPLINT, INTRANASAL SEPTAL LYA MEDTRONIC XOMED INC. CG1000 0209026478

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other