BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEXIS

    MDR report key: 10754895 · Received October 29, 2020

    Report

    Report Number
    10754895
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 14, 2020
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON NOTED TEAR BETWEEN THUMB AND FIRST FINGER ON THE CARDINAL HEALTH 200 PROTEXIS STERILE LATEX POWDER-FREE SURGICAL GLOVES DURING A SURGICAL CASE. THE GLOVES WERE CHANGED SEVERAL TIMES, BUT THE NEW PAIRS HAD THE SAME ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221108 PROTEXIS SURGEONS GLOVES KGO CARDINAL HEALTH 200, LLC 2D72LT90 TS1910081, TS20020101

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA