BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VINYL EXAM GLOVE

    MDR report key: 3833423 · Received May 19, 2014

    Report

    Report Number
    1417592-2014-00048
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    February 26, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END USER DEVELOPED A RASH ON HER HANDS AFTER WEARING THE GLOVES. SHE SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ORAL STEROIDS. NO SERIOUS INJURY RESULTED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NO TREND FOR IRRITATION ISSUES RELATED TO USE OF THIS GLOVE.

    Description of Event or Problem · 1

    THE END USER DEVELOPED A RASH AFTER WEARING THE GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295458 VINYL EXAM GLOVE LYZ MEDLINE INDUSTRIES, INC. MA306619010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention