BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3151345 · Received May 6, 2013

    Report

    Report Number
    3151345
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    A #10 SURGICAL BLADE THAT WAS INCLUDED IN THE EP IMPLANT TRAY WAS STUCK TO THE STERILE PACKAGING THAT HELD THE PRODUCT. THE PACKAGING REMAINED ON THE BLADE AFTER OPENING THE PRODUCT. THE STERILE BLADE AND BLADE PACKAGING WAS REMOVED FROM THE STERILE FIELD. NO PATIENT HARM INFLICTED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197891 * KIT, SURGICAL INSTRUMENT KDD AVID MEDICAL, INC. * 886535

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR