BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM STRETCHY NITRATE

    MDR report key: 7112091 · Received December 12, 2017

    Report

    Report Number
    MW5073933
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 11, 2017
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN REMOVED GLOVE FROM BOX AND DONNED GLOVE IN USUAL FASHION. RN VERBALIZED "GRITTY" SENSATION IN GLOVE. GLOVE REMOVED AND EXAMINED TO FIND LARGE BROWN FOUL FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886429 ESTEEM STRETCHY NITRATE VINYL PATIENT EXAMINATION GLOVE LYZ CARDINAL HEALTH 8817NB 9C17K002

    Patients

    Seq Age Sex Outcome Treatment
    1