BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLACK COLORED, NON-STERILE

    MDR report key: 21634255 · Received March 18, 2025

    Report

    Report Number
    MW5167781
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    January 30, 2024
    Report Date
    March 14, 2025
    Manufacturer
    KOSSAN INTERNATIONAL SDN BHD
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT¿S CAREGIVER CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT ORDER (B)(4) NOT BEING DELIVERED ON 1/30 AS EXPECTED SHE HAD TO USE LARGE GLOVES INSTEAD OF EXTRA-LARGE GLOVES. THIS CAUSED BRUISING ON HER HANDS. 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
    1212738 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLACK COLORED, NON-STERILE POLYMER PATIENT EXAMINATION GLOVE LZA KOSSAN INTERNATIONAL SDN BHD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown