BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOVE PROTEGRITY MICRO PF LATEX SURG 8.0

    MDR report key: 1200284 · Received October 1, 2008

    Report

    Report Number
    1423507-2008-00076
    Event Type
    Other
    Date Received
    October 1, 2008
    Date of Event
    June 6, 2008
    Report Date
    October 1, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO PROVIDE THE SAMPLE OR THE LOT NUMBER, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THE ROOT CAUSE WAS PROBABLY DUE TO A THIN SPOT ON THE LATEX FILM GIVING WAY TO A TEAR OR HOLE DURING USE. CURRENTLY THERE IS AN ESTABLISHED MOLD MAINTENANCE PROGRAM AND A FILTRATION PROCESS IN ORDER TO PREVENT THESE OCCURRENCES. EVERY LOT PRODUCTION IS TESTED USING FDA PRESCRIBED WATER TEST PROCEDURE. THIS APPEARS TO BE AN ISOLATED INCIDENT. MANUFACTURING WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A SURGEON, WHO WAS DOUBLE GLOVED, NOTICED BLOOD ON HIS FINGERS WHEN HE TOOK HIS GLOVES OFF AFTER PERFORMING A HIP PROSTHESIS SURGERY. TRITHERAPY WAS ADMINISTERED TO THE SURGEON AS PREVENTATIVE TREATMENT. THIS IS ONE OF THE GLOVE CATALOG NUMBERS HE WORE. PREVIOUSLY SUBMITTED MEDWATCH 1423507-2008-00075 WAS FOR THE OTHER CATALOG NUMBER THE SURGEON DOUBLE GLOVED WITH.

    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 UNK Other