BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSL (ITEM 1620M)

    MDR report key: 2553736 · Received April 24, 2012

    Report

    Report Number
    MW5025180
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    April 24, 2012
    Report Date
    April 24, 2012
    Manufacturer
    CARDINAL PRIME VENDOR
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE STOCKING OF THE SHELVES, THE INVENTORY STAFF NOTICED BROWN DISCOLORATION OF THE DUST COVER ON THE 16 FR FOLEY KITS PRODUCED BY LSL (ITEM 1620M) AND RECEIVED THROUGH CARDINAL PRIME VENDOR. LOT # 003154 EXP 11/2012. THE STOCK WAS REVIEWED AND THIS LOT NUMBER SEQUESTERED. SINCE THE INITIAL FINDING, INVENTORY STAFF REQUESTED REPLACEMENT THROUGH THE CARDINAL PRIME VENDOR, HOWEVER, THE REPLACEMENT STOCK WAS THE SAME LOT NUMBER AND SIMILAR DISCOLORATION CAN BE FOUND ON OTHER CASES ASSOCIATED WITH THIS LOT NUMBER. WE ARE WORKING WITH THE PRIME VENDOR TO RETURN 4 CASES AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSL (ITEM 1620M) 16 FR FOLEY KITS KOD CARDINAL PRIME VENDOR 003154

    Patients

    Seq Age Sex Outcome Treatment
    1