BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOVE, EXAM, ALOETOUCH 3G, PF SY

    MDR report key: 1221816 · Received October 30, 2008

    Report

    Report Number
    1417592-2008-00038
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CLINICIAN WAS WEARING THE GLOVES IN THE OR TO PICK UP BLOODY SPONGES FROM A HEART PROCEDURE. WHEN SHE REMOVED HER GLOVES, SHE STATES THERE WAS BLOOD INSIDE ON HER HAND. SHE HAD A SKIN ABRASION ON HER HAND. THERE WERE NO OBVIOUS RIPS OR TEARS IN THE GLOVES. THE PATIENT WAS TESTED AND THE RESULTS CAME BACK POSITIVE FOR HEPATITIS C. THE CLINICIAN WAS ALSO TESTED BUT HER RESULTS HAVE NOT YET COME BACK. THE ACTUAL GLOVE INVOLVED IN THE INCIDENT WAS NOT RETAINED FOR EVALUATION. TWO INDIVIDUAL PARTIAL BOXES WERE RETURNED FOR EVALUATION. THE GLOVES WERE WATER TESTED AND NO LEAKS WERE IDENTIFIED.

    Description of Event or Problem · 1

    STAFF MEMBER IN OR REMOVED EXAM GLOVE AND FOUND BLOOD ON HER HAND. NO RIPS OR TEARS IDENTIFIED ON THE GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE, EXAM, ALOETOUCH 3G, PF SY NONE LYY MEDLINE INDUSTRIES, INC. MDS195175 MG803824612

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other