BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLV EXAM N/S LATEX TXT PF INSTAGARD MD

    MDR report key: 516755 · Received March 19, 2004

    Report

    Report Number
    6000008-2004-00001
    Event Type
    Other
    Date Received
    March 19, 2004
    Report Date
    March 19, 2004
    Manufacturer
    CARDINAL HEALTH - DISTRIBUTION
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE RN TOOK THEIR GLOVES OFF, THERE WAS BLOOD ON THEIR HANDS. THEY HAD BEEN PUTTING THE PRODUCTS OF MISCONCEPTION (MISCARRIAGE PT) INTO A SPECIMEN CONTAINER. THE PT WAS HIV+ BOTH THE PT AND THE NURSE WERE "WORKED UP" AND THE PT DID TEST POSITIVE FOR HIV. THE HOSP'S BLOOD EXPOSURE PROTOCOL WAS INITIATED FOR THE NURSE. THE NURSE CHOSE NOT TO TAKE THE PROPHYLACTIC MEDICATION, BUT WILL CONTINUE TO BE MONITORED. THE NURSE DID NOT HAVE ANY CUTS ON THEIR HANDS, BUT WAS UNSURE OF THE CUTICLE AREA. INCIDENT TIME FRAME IS 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV EXAM N/S LATEX TXT PF INSTAGARD MD EXAM GLOVES LYY CARDINAL HEALTH - DISTRIBUTION 8847A 4H03J017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other