BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLV SURG PF LTX UNDRGLV PROTEG BLU 8.0

    MDR report key: 1172661 · Received September 15, 2008

    Report

    Report Number
    1423507-2008-00075
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    June 6, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND HISTORICAL TRENDING WAS PERFORMED. NO TRENDS WERE FOUND. SAMPLES WERE RECEIVED AND EVALUATED, WITH TESTING REVEALING A SMALL TEAR AT THE ROOT OF THE SMALL FINGER OF THE RIGHT GLOVE. THE ROOT CAUSE OF THE TEAR WAS PROBABLY DUE TO A THIN SPOT ON THE LATEX FILM GIVING WAY TO A TEAR OR HOLE DURING THE GLOVE STRIPPING PROCESS. THE FORMING TEAM NOTIFIED THE LATEX TEAM REGARDING FINDINGS. CURRENTLY, THERE IS AN ESTABLISHED MOLD MAINTENANCE PROGRAM AND A FILTRATION PROCESS IN ORDER TO PREVENT THESE ISOLATED OCCURRENCES. EVERY LOT PRODUCTION IS TESTED USING THE FDA PRESCRIBED WATER TEST PROCEDURE. THE AQL IS MUCH TIGHTER THAN THAT REQUIRED BY THE FDA. THIS APPEARS TO BE AN ISOLATED INCIDENT AND MFG WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A SURGEON 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. NO DEFECT WAS NOTICED ON THE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV SURG PF LTX UNDRGLV PROTEG BLU 8.0 SURGEONS GLOVE KGO CARDINAL HEALTH TS0703652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other