BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE SOURCE DIRECT MEDICAL GLOVES

    MDR report key: 17692008 · Received September 5, 2023

    Report

    Report Number
    MW5145215
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 30, 2023
    Manufacturer
    SAFESOURCE DIRECT GLOVE PLANT
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WERE SOME GLOVES WITH TEARS AND STAINS, SEEM LIKE PRODUCTS MAY HAVE BEEN TAMPERED. THE SMELL OF A NEW BOX OF GLOVES WAS ALSO UNBEARABLE. THE GLOVES CAUSED SKIN IRRITATION AND RASHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120869 SAFE SOURCE DIRECT MEDICAL GLOVES POLYMER PATIENT EXAMINATION GLOVE LZA SAFESOURCE DIRECT GLOVE PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other