BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRUB CARE DRY SKIN PREP TRAY

    MDR report key: 2682949 · Received August 2, 2012

    Report

    Report Number
    2682949
    Event Type
    Malfunction
    Date Received
    August 2, 2012
    Date of Event
    July 23, 2012
    Report Date
    August 2, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    OJU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    GRAY/BLACK FLECKS OF DEBRIS WERE FOUND IN 2 SEPARATE PACKAGES OF STERILE DRY SKIN PREPARATION TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRUB CARE DRY SKIN PREP TRAY STERILE DRY SKIN PREP TRAYS OJU CARDINAL HEALTH * 0000434391
    2 SCRUB CARE DRY SKIN PREP TRAYS STERILE DRY SKIN PREP TRAYS OJU CARDINAL HEALTH * 0000436901

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO