BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALENGER SWIVEL KNIFE

    MDR report key: 85310 · Received April 22, 1997

    Report

    Report Number
    85310
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 17, 1997
    Report Date
    March 21, 1997
    Manufacturer
    ALLEGIANCE V MUELLER
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE, BLADE OF SWIVEL KNIFE BROKE OFF IN PT'S NOSE. UNABLE TO BE RETRIEVED. NO KNOWN UNTOWARD EFFECTS TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALENGER SWIVEL KNIFE SURGICAL SWIVEL KNIFE KTG ALLEGIANCE V MUELLER 7 3/4" LONG/3MM WIDE *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR