BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN SHAVER PREP RAZOR STERILE

    MDR report key: 1051917 · Received May 23, 2008

    Report

    Report Number
    9612030-2008-00012
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 25, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN '08 THAT A CUSTOMER HAD A PROBLEM WITH A PREP RAZOR. THE CUSTOMER REPORTS THAT AN EMPLOYEE CUT THEMSELVES TRYING TO REMOVE THE CAP FROM A RAZOR. THE RAZOR WAS GRABBED FROM BOTH SIDES IN ORDER TO REMOVE THE CAP. THE EMPLOYEE REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN SHAVER PREP RAZOR STERILE PREP RAZOR LWK TYCO HEALTHCARE/KENDALL 45119 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK