BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOMED SILASTIC NS BUTTON

    MDR report key: 159121 · Received March 20, 1998

    Report

    Report Number
    MW1013371
    Event Type
    Injury
    Date Received
    March 20, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 6, 1998
    Manufacturer
    KOMED SURGICAL PRODUCTS
    Product Code
    LFB
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 49 YR OLD PT W/NASAL SEPTAL PERFORATION HAD A SEPTAL BUTTON PLACED 8/2/95. PT DID WELL UNTIL 3/1/98. SPONTANEOUS EXTRUSION OCCURRED. PT FELT ASPIRATION GAVE HIMSELF 2 HEIMLICH MANEUVERS AND DISLODGED IT. HE STATED CONNECTING PORTION OF PROSTHESIS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOMED SILASTIC NS BUTTON Implant SILASTIC NASAL SEPTAL BUTTON LFB KOMED SURGICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening