BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITRILE EXAM GLOVE MEDIUM

    MDR report key: 21587245 · Received March 12, 2025

    Report

    Report Number
    MW5167609
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 7, 2025
    Manufacturer
    KOSSAN RUBBER INDUSTRIES / KOSSAN LATEX INDUSTRIES (M) SDN BHD
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT HIS WIFE'S HANDS ARE IRRITATED AFTER USING THE NITRILE EXAM GLOVES. PATIENT WAS ADVISED TO CONTACT THE REGISTERED NURSE SO SHE IS AWARE OF IT AND SHE CAN DECIDE WHAT OTHER GLOVES CAN BE ADDED TO THE PRESCRIPTION. THE PATIENT STATED HE WILL TALK TO THEIR RN AND THAT THIS ISSUE HAS BEEN GOING FOR ABOUT SIX WEEKS. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689851 NITRILE EXAM GLOVE MEDIUM POLYMER PATIENT EXAMINATION GLOVE LZA KOSSAN RUBBER INDUSTRIES / KOSSAN LATEX INDUSTRIES (M) SDN BHD 031031103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown