BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXAM GLOVES

    MDR report key: 14073600 · Received April 11, 2022

    Report

    Report Number
    14073600
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    November 10, 2021
    Report Date
    November 18, 2021
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    LZC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON ENTERING THE PATIENT ROOM, I GRABBED 2 MEDIUM GLOVES FROM A NEARLY NEW BOX OF GLOVES. (THE GLOVES WERE OBVIOUSLY NOT USED AS THEY WERE FLAT AND CRINKLED.) I SLID THE GLOVE ONTO MY LEFT HAND AND IMMEDIATELY FELT THAT THERE WAS A FOREIGN OBJECT IN 2 OF THE FINGERS OF THE GLOVES. I PEELED OFF THE GLOVE TO FIND A DRY CRUMBLY BROWN SUBSTANCE IN THE FINGERTIPS OF THE GLOVES. UPON INSPECTION OF MY FINGER, I FOUND THE BROWN SUBSTANCE FROM THE GLOVE UNDER MY FINGERNAIL. I THEN COLLECTED THE GLOVE IN A BAG AND REMOVED THE BOX OF GLOVES FROM THE PATIENT ROOM AND REPORTED IT TO THE UNIT MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403449 EXAM GLOVES PATIENT EXAMINATION GLOVE, SPECIALTY LZC MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown