BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON SURGICAL BLADES 15

    MDR report key: 1509922 · Received September 28, 2009

    Report

    Report Number
    1221336-2009-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Date of Event
    June 11, 2009
    Report Date
    September 28, 2009
    Manufacturer
    MILTEX, INC.
    Product Code
    KTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE RN SUPERVISOR REPORTED VIA TELEPHONE. THE DOCTOR RECORDED IN THE PATIENT'S CHART THAT THE TIP OF THE #15 BLADE BROKE WHERE IT ATTACHED TO THE SCALPEL HANDLE DURING AN OPEN RHINOPLASTY WITH SEPTOPLASTY, BILATERAL INFERIOR TURBINATE INFRACTURE AND MUCOSAL COAGULATION. HE WAS UNABLE TO LOCATE/REMOVE THE ONE BROKEN PIECE. AN X-RAY SHOWED THE PIECE OF BLADE IN THE PATIENT'S STOMACH. IT WAS REMOVED VIA ENDOSCOPY WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARBON SURGICAL BLADES 15 M5 - GENERAL SURGERY KTG MILTEX, INC. C08F02

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR