BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL

    MDR report key: 8339083 · Received February 14, 2019

    Report

    Report Number
    8022032-2019-00001
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 14, 2019
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUT TO THE FINGER OCCURED WHEN THE DOCTOR LOCKED THE SCALPEL GUARD AND THEN ATTEMPTED TO OPEN IT. IT WAS NOTED THAT THE DOCTOR DOES NOT NORMALLY USE SOUTHMEDIC SCALPELS; THE DOCTOR NORMALLY USES ANOTHER BRAND WHICH REQUIRES THE USER TO PUSH FORWARDS TO OPEN THE SCALPEL. THE GUARD OF THE SOUTHMEDIC SCALPELS LOCK WHEN IT IS PUSHED FORWARD. THE DOCTOR ATTEMPTED TO USE A SOUTHMEDIC SCALPEL IN THE SAME MANNER AS ANOTHER BRAND. WHEN THE MECHANISM LOCKED THE DOCTOR TRIED TO OPEN THE GUARD BY MEANS UNKNOWN AND IN DOING SO THEY CUT THEMSELVES.

    Description of Event or Problem · 1

    DOCTOR WAS CUT ON THE FINGER WHILE ATTEMPTING TO OPEN THE SCALPEL GUARD WHEN IT WAS IN A LOCKED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133694 SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL SCALPEL GES SOUTHMEDIC INC. 73-0610 050418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other