BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLENGER SWIVEL KNIFE

    MDR report key: 85339 · Received April 22, 1997

    Report

    Report Number
    1423537-1997-00068
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 17, 1997
    Report Date
    March 21, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT DURING USE, THE BLADE OF THE KNIFE BROKE OFF IN THE PT'S NOSE. UNABLE TO RETRIEVE. NO UNTOWARD EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLENGER SWIVEL KNIFE SWIVEL KNIFE KTG ALLEGIANCE HEALTHCARE CORP. RH762 X

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other