BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM STRETCHY SYNTH EXAM GLOVE

    MDR report key: 2439343 · Received February 6, 2012

    Report

    Report Number
    1423537-2012-00004
    Event Type
    Injury
    Date Received
    February 6, 2012
    Date of Event
    January 7, 2012
    Report Date
    February 6, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING WAS DONE. AN INVESTIGATION WAS INITIATED PER THE RECEIVED PHOTO. THE WRAPPED BLADE IS USED BY THE EMPLOYEE TO CUT OFF THE SEALING TAPE TO THE SHIPPING CASE. ONE OF THE EMPLOYEES ACCIDENTALLY DROPPED THE BLADE INTO THE BOX WHILE PACKING. THE MANUFACTURER/SUPPLIER, (B)(4), WAS APPRISED OF THIS COMPLAINT FOR CLOSE MONITORING DURING THE PACKING PROCESS. ACTIONS TO BE TAKEN ARE: (B)(4).

    Description of Event or Problem · 1

    A REHABILITATION NURSING TECHNICIAN BEGAN TO OPEN A BOX OF GLOVES BY PULLING OPEN THE PERFORATED TAB ON THE TOP OF THE BOX AND WAS "SCRATCHED" BY AN OBJECT INSIDE THE BOX. WHEN THE BOX WAS FULLY OPENED A "WRAPPED BLADE" WAS INSIDE THE BOX AT THE VERY TOP UNDER THE PERFORATED TAB. IT APPEARED TO BE SIMILAR TO A BOX CUTTER BLADE, WRAPPED IN HEAVY PAPER AND THEN WRAPPED AGAIN WITH HEAVY TAPE. THE EMPLOYEE'S SKIN WAS BROKEN SLIGHTLY BUT DID NOT BLEED. SHE RECEIVED MEDICAL ATTENTION AND TESTING THAT HER EMPLOYER DOES WHEN THERE IS EXPOSURE TO BODY FLUIDS, INCLUDING A TETANUS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTEEM STRETCHY SYNTH EXAM GLOVE VINYL PATIENT EXAMINATION GLOVE LYZ CARDINAL HEALTH 6Y11N023

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other