BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 2939276 · Received January 29, 2013

    Report

    Report Number
    3004605321-2013-00001
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    S&S SURGICAL
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BLADE WAS STICKING OUT FROM ONE OF THE BOTTOM FLAPS OF THE BOX. WHEN OPENED THE EMPLOYEE CONTACTED THE BLADE AND RECEIVED A LACERATION REQUIRING A TRIP TO THE HOSPITAL, 3 X-RAYS, A TETANUS SHOT, AND THREE STITCHES ON HER INDEX FINGER. DEROYAL: PICTURES OF THE DEFECT WERE RECEIVED FOR OUR INVESTIGATION. INTERNAL INSPECTIONS WERE PERFORMED DURING THE RELABELING PROCESS AND ON FINISHED GOODS WHERE NO DEFECTS WERE FOUND. AS A CORRECTIVE ACTION ALL APPLICABLE PERSONNEL RECEIVED RETRAINING FOR HEIGHTENED AWARENESS WHEN PACKAGING THIS PRODUCT TO VERIFY THAT THE BLADES ARE NOT EXPOSED. THE PRODUCT IS UNDER 100% INSPECTION TO VERIFY ALL BLADES ARE RETRACTED PRIOR TO PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLADE WAS STICKING OUT FROM ONE OF THE BOTTOM FLAPS OF THE BOX. WHEN OPENED THE EMPLOYEE CONTACTED THE BLADE AND RECEIVED A LACERATION REQUIRING A TRIP TO THE HOSPITAL, 3 X-RAYS, A TETANUS SHOT, AND THREE STITCHES ON HER INDEX FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38623 DEROYAL GDZ - HANDLE, SCALPEL GDZ S&S SURGICAL 29888883

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization