BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL GLOVES

    MDR report key: 6106250 · Received November 16, 2016

    Report

    Report Number
    1423537-2016-00059
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CARDINAL HEALTH (THAILAND) 222 LIMITED
    Product Code
    KGO
    UDI-DI
    10885380124341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP REPORT BASED ON SAMPLE RECEIPT. THE DEVICE HISTORY RECORD OF THE COMPLAINT LOT WAS REVIEWED. THE LOT WAS INSPECTED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. HISTORICAL TRENDING WAS DONE. THE RETURNED SAMPLE RECEIVED WAS A "REPRESENTATIVE" GLOVE SAMPLE. EVALUATION WAS DONE BY PHYSICAL PROPERTIES TESTING, WHICH FOUND THE TENSILE STRENGTH AND THICKNESS TESTING WERE WITHIN SPECIFICATION.  THEREFORE AN EXACT ROOT CAUSE COULD NOT BE DETERMINED .WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY UNFAVORABLE TRENDS, WHICH MIGHT REQUIRE FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT FORWARDED TO PLANT FOR INVESTIGATION, AND THE SAMPLE IS BEING RETRIEVED. WILL FILE FOLLOW UP REPORT ONCE THEIR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE SURGEON NOTICED AT THE END OF AN OPHTHALMOLOGIC PROCEDURE THAT THE MIDDLE FINGER OF THE GLOVE WAS TORN. ON (B)(6) 2016 IT WAS LEARNED THAT PROPHYLACTIC ANTIBIOTIC TREATMENT WAS APPLIED TO THE PATIENT AT THE END OF THE CASE BECAUSE OF THE TORN GLOVE. NO OTHER INFORMATION WAS PROVIDED ABOUT THE PATIENT AS THE CUSTOMER CONSIDERED THIS INFORMATION CONFIDENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758546 CARDINAL GLOVES SURGEON'S GLOVES KGO CARDINAL HEALTH (THAILAND) 222 LIMITED TS16050063 10885380124341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other