BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    00247 CURITY PREP RAZOR COMB/COMB BULK

    MDR report key: 1021891 · Received March 28, 2008

    Report

    Report Number
    1282497-2008-00009
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    AMERICAN SAFETY RAZOR CO
    Product Code
    LWK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 2008 THAT A CUSTOMER HAD A PROBLEM WITH A PREP RAZOR. THE CUSTOMER STATED THAT A STAFF MEMBER WAS INJURED DUE TO PLACING FINGER ON BLADE SIDE OF RAZOR TO REMOVE COVER. STAFF MEMBER SUFFERED FROM LACERATION OF FINGER THAT REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 00247 CURITY PREP RAZOR COMB/COMB BULK PREP RAZOR LWK AMERICAN SAFETY RAZOR CO 139083 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK