BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM XP NITRILE

    MDR report key: 3672174 · Received March 5, 2014

    Report

    Report Number
    3672174
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    CARDINAL HEALTH INC.
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    GLOVES WERE PULLED OUT OF THE BOX WITHOUT DIFFICULTY AND PUT ON. A HOLE WAS IN THE THUMB OF THE GLOVES. NO HARM TO PATIENT OR STAFF. HOLE WAS VISIBLY EVIDENT. ANOTHER GLOVE OBTAINED AND CARE CONTINUED. THIS FACILITY HAS HAD MULTIPLE SIMILAR EVENTS WITH THIS DEVICE/PRODUCT WITHIN A TWO MONTH TIME SPAN. THE MANUFACTURER HAS BEEN NOTIFIED AND IS TESTING THE DEVICE/PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131316 ESTEEM XP NITRILE PATIENT EXAMINATION GLOVE LZC CARDINAL HEALTH INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR