BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONNA PLUS BLADE, NON-STERILE

    MDR report key: 2655763 · Received July 13, 2012

    Report

    Report Number
    8022032-2012-00001
    Event Type
    Injury
    Date Received
    July 13, 2012
    Date of Event
    June 20, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUARD WAS STILL INTACT ON THE SAFETY SCALPEL. GUARD PLACEMENT IS INSPECTED 200% PRIOR TO RELEASE AT SOUTHMEDIC INC. UPON RECEIPT OF THE SAFETY SCALPELS AT CARDINAL HEALTH, THEY ARE REPACKAGED AND STERILIZED INTO THE AFOREMENTIONED C-SECTION KIT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT WHEN THEY OPENED THE C-SECTION PACK, AN EMPLOYEE WAS CUT WITH AN UNPROTECTED KNIFE WHEN THEY REMOVED THE TOWELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERSONNA PLUS BLADE, NON-STERILE SCALPEL GES SOUTHMEDIC INC. 73-1810 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization C-SECTION PACK