BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN,FLAT,7MMX4MM

    MDR report key: 511632 · Received January 16, 2004

    Report

    Report Number
    1423507-2004-00006
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 16, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THAT THE WOUND DRAIN BROKE IN THE PT AND HAD TO BE REMOVED. THE PT IS FINE AND NOT IN ANY DANGER. THE CUSTOMER COULD NOT PROVIDE CO WITH THE LOT NUMBER BUT SAID IT WAS PULLED FROM THE SHELF NEXT TO THE SAME PRODUCT WITH LOT #1990594. ADD'L NUMBERS ON THAT SAMPLE PACKAGE WERE 102506-001-01. THE DRAIN WAS REMOVED FROM THE PT IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN,FLAT,7MMX4MM FLAT WOUND DRAIN GCY CARDINAL HEALTH SU130-1310 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention