BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAZOR PREP SINGLE USE

    MDR report key: 664239 · Received January 13, 2006

    Report

    Report Number
    1423507-2006-00002
    Event Type
    Other
    Date Received
    January 13, 2006
    Date of Event
    November 1, 2005
    Report Date
    January 13, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LWK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN NURSE WAS REMOVING THE PROTECTIVE COVER FROM THE RAZOR HEAD, THE BLUE RAZOR TOP CAME OFF AS WELL, EXPOSING THE ENTIRE RAZOR BLADE. PRODUCT MOST LIKELY CAME FROM ONE OF THESE LOTS: 05-1508-1, KF-2004-1415-1 OR 04-1416-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAZOR PREP SINGLE USE SINGLE USE PREP RAZOR LWK CARDINAL HEALTH 4415B SEE B.5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other