BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY SCALPELS

    MDR report key: 2609340 · Received February 24, 2009

    Report

    Report Number
    8044030-2009-00001
    Event Type
    Injury
    Date Received
    February 24, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 14, 2009
    Manufacturer
    JAI SURGICALS LTD.
    Product Code
    EME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCALPEL WAS SUPPLIED TO USER AS PART OF A KIT. AS JAI DOES NOT MANUFACTURE THE KIT, WE ARE NOT AWARE OF HOW THE SCALPEL IS PRESENTED. THERE WAS NO INFORMATION AS WHETHER THE FACILITY HAS A PROGRAMM FOR TRAINING USERS. WHILST THE PRODUCT IS NOT CONSIDERED AS DEFECTIVE, ACTION IS BEING TAKEN TO EVALUATE HOW IMPROVEMENTS CAN BE MADE.

    Description of Event or Problem · 1

    THE PHYSICIAN HELD THE SCALPEL UPSIDE DOWN, SO WHEN HE SLID THE RETRACTION MECHANISM, HE OPENED THE CONTAMINATED BLADE INTO THE PALM OF HIS HAND. SCALPEL WAS SOMEWHAT NEW TO PHYSICIAN. FACILITY HAS SUGGESTED IMPROVING THE MARKINGS ON THE SCALPEL HANDLE WHICH WERE DIFFICULT TO READ UNDER THE LOW LIGHT CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SCALPELS EME JAI SURGICALS LTD. 11 6114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention