BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON 15MM JAW40DG-UP4MM203MM

    MDR report key: 624085 · Received July 16, 2005

    Report

    Report Number
    2916714-2005-00035
    Event Type
    Malfunction
    Date Received
    July 16, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 29, 2005
    Manufacturer
    AESCULAP, INC.
    Product Code
    GXJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SCREW ON THE KERRISON LOOSENED DURING USE AND FELL INTO THE WOUND OF A PT. X-RAY TAKEN TO LOCATE AND RETRIEVE BROKEN PIECE. SURGERY PROLONGED 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON 15MM JAW40DG-UP4MM203MM RONGEUR GXJ AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN