BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 165633 · Received April 29, 1998

    Report

    Report Number
    1045254-1998-00002
    Event Type
    Injury
    Date Received
    April 29, 1998
    Date of Event
    March 1, 1998
    Report Date
    April 27, 1998
    Manufacturer
    XOMED SURGICAL PRODUCTS, INC.
    Product Code
    LFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY THAT "49 YEAR OLD PT WITH NASAL SEPTAL PERFORATION, SEPTAL BUTTON PLACED 8/2/95, PT DID WELL UNTIL 3/1/98. SPONTANEOUS EXTRUSION. PT FELT ASPIRATION GAVE HIMSELF 2 HEIMLEICH MANUEVERS AND DISLODGED. HE STATES CONNECTING PORTION OF PROSTHESIS BROKEN." IT WAS ADDITIONALLY REPORTED TO MFR THAT "PT IS FINE, NO PRE-EXISTING MEDICAL CONDITIONS EXISTED THAT CONTRIBUTED TO EVENT, DEVICE JUST CAME APART."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA Implant TWO-PART ADJUSTABLE SEPTAL BUTTON LFB XOMED SURGICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening