BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONJEUR

    MDR report key: 16794687 · Received April 24, 2023

    Report

    Report Number
    16794687
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    June 26, 2017
    Report Date
    July 17, 2017
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE, THE 340 KERRISON INSTRUMENT FELL APART. THERE WERE NO FRAGMENTS RETAINED AND NO APPARENT PATIENT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443614 KERRISON RONJEUR RONGEUR, MANUAL HAE BOSS INSTRUMENTS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Female