BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE

    MDR report key: 542984 · Received September 10, 2004

    Report

    Report Number
    542984
    Event Type
    Other
    Date Received
    September 10, 2004
    Date of Event
    July 1, 2004
    Report Date
    August 1, 2004
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDX
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS ATTEMPTING TO REMOVE PLASTIC SHIELD/COVER FORM MEDLINE DISPOSABLE #11 STERILE SCALPEL. THE BLADE ON THE SCALPEL IS NOT PROTECTED ONCE THIS SHIELD/COVER IS REMOVED. SHIELD WAS DIFFICULT TO REMOVE AND WHEN IT DID COME OFF THE BLADE CAUSED A DEEP LACERATION TO THE RIGHT ULNAR ASPECT OF THE PALM OF HAND WHICH HAD TO BE REPAIRED, SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLINE 11 STAINLESS STEEL DISPOSABLE STERILE SCALPEL GDX MEDLINE INDUSTRIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other