BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIFLEX SURGEON'S GLOVE, 8

    MDR report key: 1594119 · Received January 25, 2010

    Report

    Report Number
    1423507-2010-00003
    Event Type
    Other
    Date Received
    January 25, 2010
    Date of Event
    November 19, 2009
    Report Date
    January 21, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICAL COMPLAINT DATA WAS REVIEWED AND NO TREND WAS FOUND. THE RETURNED SAMPLE WAS EXAMINED AND A VISUAL HOLE WAS FOUND ON THE TIP OF THE INDEX FINGER. THE MOST PROBABLE CAUSE COULD BE MOLD TOUCHING AND A REVIEW OF THE DEVICE MASTER RECORD CONFIRMED THERE WAS AN ISOLATED INCIDENT OF TOUCHING AND THAT THE PRODUCTION LOTS MET THE ACCEPTABLE CRITERIA. THE CORRECTIVE ACTION IS THAT THE AFFECTED MOLD WILL BE REPLACED WITH AN ADJUSTED NEW ONE, AND THE ALIGNMENT OF THE U-BRACKET OF THE CHAIN LINK HAS BEEN ALSO ADJUSTED TO PREVENT REOCCURRENCE. WE WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    AT THE END OF A PACEMAKER IMPLANT, THE SURGEON SAW BLOOD ON THE SECOND FINGER OF HIS RIGHT HAND - HOLE IN GLOVE. THE PT WAS HCV POSITIVE HCV POSITIVE. THE SURGEON IS UNDER OBSERVATION. OCCURRENCE WAS IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFLEX SURGEON'S GLOVE, 8 SURGEON'S GLOVE KGO CARDINAL HEALTH TS09060598

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other