BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONGEUR

    MDR report key: 5045394 · Received August 26, 2015

    Report

    Report Number
    MW5055852
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 26, 2015
    Manufacturer
    INNOMED INC.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RONGEUR BROKE INTRAOP; BOTH PIECES WERE ACCOUNTED FOR - NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566351 RONGEUR HTX INNOMED INC. 1790-02

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR