BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERRISON RONGUER 3MM

    MDR report key: 14014952 · Received April 4, 2022

    Report

    Report Number
    MW5108758
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 1, 2022
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 3MM KERRISON RONGEUR IN USE, SCREW BEGAN TO BACK OUT OF KERRISON RONGEUR AND PIECES CAME APART. ALL PIECES RETRIEVED. KERRISON RONGEUR REMOVED FROM THE STERILE FIELD AND REPLACED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440304 KERRISON RONGUER 3MM RONGUER HTX LIFE INSTRUMENT CORP. 830-0803-0

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention