BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 7100903 · Received December 7, 2017

    Report

    Report Number
    MW5073845
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 6, 2017
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEW GLOVES REPEATEDLY RIPPING WHEN TAKEN OUT OF BOX AND WORN. STAFF REPORT SEVERAL SIMILAR INCIDENTS RELATED TO THIS BRAND OF GLOVE. RIPPED GLOVES ARE DISCARDED. NEW GLOVES ARE UTILIZED. NO REPORTS OF PATIENT OR STAFF HARM AS A RESULT OF THE WEAK GLOVES HAVE BEEN MADE. SPECIFIC PATIENT NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878024 ESTEEM STRETCHY NITRILE GLOVES LZC CARDINAL HEALTH 7F17D508

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA