BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JANSON-MIDDLETON RONGEUR

    MDR report key: 74481 · Received March 7, 1997

    Report

    Report Number
    MW1010895
    Event Type
    Malfunction
    Date Received
    March 7, 1997
    Date of Event
    February 21, 1997
    Report Date
    February 24, 1997
    Manufacturer
    AESCULAP
    Product Code
    KBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE DESCRIBED AS NASAL RECONSTRUCTION FOR NASAL SEPTAL DEFECT, THE TIP OF A RONGEUR BROKE INSIDE THE PT'S NOSE. THE PIECE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JANSON-MIDDLETON RONGEUR NASAL RONGEUR KBB AESCULAP OK405 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR