BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCALPEL, SAFETY #11, SS, STERIL

    MDR report key: 1291843 · Received January 19, 2009

    Report

    Report Number
    1417592-2009-00005
    Event Type
    Other
    Date Received
    January 19, 2009
    Date of Event
    December 29, 2008
    Report Date
    January 15, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STAFF MEMBER WAS INJURED WHEN TRYING TO ACTIVATE THE SAFETY MECHANISM ON THE SAFETY SCALPEL. THE EMPLOYEE HEALTH NURSE AT THE FACILITY WAS NOT AWARE THAT THIS PRODUCT HAD BEEN INTRODUCED AND DID NOT KNOW IF ANY FORMAL PRODUCT TRAINING HAD BEEN PROVIDED. THE INJURY OCCURRED ON 12/29 AND RESULTED IN A FINGER LACERATION WITH A CONTAMINATED BLADE. TESTING RESULTS WERE NOT BACK ON THE SOURCE INDIVIDUAL BUT DUE TO INFORMATION GATHERED PERTAINING TO THE PATIENT'S LIFESTYLE, THEY OPTED TO PROVIDE POST EXPOSURE PROPHYLACTIC TREATMENT TO THE STAFF MEMBER. THE SAMPLE OF THE BLADE INVOLVED IN THE INCIDENT WAS NOT RETAINED. IT IS UNKNOWN IF THE STAFF MEMBER WAS ATTEMPTING TO ACTIVATE THE SAFETY MECHANISM ACCORDING TO THE INSTRUCTIONS. NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 1

    STAFF MEMBER INJURED WITH A CONTAMINATED SCALPEL AS SAFETY MECHANISM WAS TRYING TO BE ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCALPEL, SAFETY #11, SS, STERIL NONE GDX MEDLINE INDUSTRIES, INC. MDS15311 H02990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention