BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOVE PROTEGRITY MICRO PF LATEX SURG 8.0

    MDR report key: 1641240 · Received March 1, 2010

    Report

    Report Number
    1423507-2010-00015
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    December 11, 2009
    Report Date
    February 25, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE RETURNED SAMPLE SHOWED THREE MISSING FINGERTIPS. DURING THE PACKAGING ASSEMBLY PROCESS, A PAIR OF GLOVES IS PLACED ON A CONVEYOR WHICH FEEDS THE GLOVES INTO THE PACKAGING MACHINE. THE MACHINE AUTOMATICALLY FOLDS AND CUTS THE INNER WALLET, THUS PREPARING FOR THE FINAL POUCH PLACEMENT. ON RARE OCCASIONS THE PACKAGING MACHINE WILL STALL, RESULTING IN A DISPLACEMENT OF THE GLOVES WITHIN THE INNER WRAP PRIOR TO THE FOLDING AND CUTTING PROCESS. THIS DISPLACEMENT CAN POTENTIALLY RESULT IN THE GLOVE BEING CUT. IT HAS BEEN DETERMINED THAT THIS IS THE MOST PROBABLE CAUSE OF THE MISSING FINGERS. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE SURGEON NOTICED DURING A TOTAL HIP CASE THAT THREE FINGERTIPS WERE MISSING ON THE GLOVE. THE WOUND WAS IRRIGATED AS USUALLY DONE FOR THE CASE. AN X-RAY, USUALLY ALSO DONE FOR THE CASE, WAS DONE A LITTLE EARLIER IN THE PROCEDURE. THE FINGERTIPS WERE NOT FOUND. THIS WAS A TOP GLOVE OVER ANOTHER GLOVE. PER THE CUSTOMER, THE CASE WAS NOT DELAYED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE PROTEGRITY MICRO PF LATEX SURG 8.0 SURGEONS GLOVE KGO CARDINAL HEALTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other