BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3161408 · Received June 7, 2013

    Report

    Report Number
    3161408
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    7000 CARDINAL PLACE
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE GOWNS FROM THE ARTHROSCOPIC KNEE PACK HAD STRIKE THRU; IT WAS NOTED AT THE BEGINNING OF THE CASE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ARTHROSCOPY OF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253200 * CARDINAL HEALTH 200, LLC KKX 7000 CARDINAL PLACE * SOP45AKNCW

    Patients

    Seq Age Sex Outcome Treatment
    1 *