BEUDAMED
    FDA Adverse Event Other Summary report: N

    BASIC PACK (BSRJJ)115

    MDR report key: 538232 · Received August 10, 2004

    Report

    Report Number
    1423507-2004-00079
    Event Type
    Other
    Date Received
    August 10, 2004
    Date of Event
    July 22, 2004
    Report Date
    August 10, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE SCRUB TECH WAS OPENING THE ZIP LOCK BAG THAT CONTAINS THE SMALL ITEMS, THE NUMBER 15 SCALPEL POPPED OUT OF THE BAG AND STABBED THE SCRUB TECH IN THE CHEST WHICH MADE A SMALL CUT THAT DREW BLOOD. THE BLADE OF THE SAFETY SCALPEL WAS EXPOSED. TREATMENT CONSISTED OF A TETANUS SHOT. 072604 COMPONENT MFR IS PERSONAL SAFETY RAZOR, REFERENCE NUMBER IS 0423 AND THEY HAVE DECLINED TO FILE A MEDWATCH, CARDINAL HEALTH IS FILING AS THE MFR OF THE CUSTOMR STERILE PACK THAT CONTAINS THE SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASIC PACK (BSRJJ)115 BASIC PACK LRO CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention