BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHARMA-GLOVE STERILE 12 INCH, DISPOSABLE, NITRILE, POWDER FREE, TEXTURED EXAM GL

    MDR report key: 21422610 · Received February 20, 2025

    Report

    Report Number
    MW5166554
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 4, 2025
    Report Date
    February 15, 2025
    Manufacturer
    PHARMA-CHOICE FOR ACUTE CARE PHARMACEUTICALS
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON OPENING A PACKAGE OF STERILE GLOVES, BLACK MARKS FOUND TO BE ON THEM. BATCH NO.: N820424.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045763 PHARMA-GLOVE STERILE 12 INCH, DISPOSABLE, NITRILE, POWDER FREE, TEXTURED EXAM GL SURGEON'S GLOVES KGO PHARMA-CHOICE FOR ACUTE CARE PHARMACEUTICALS N82/FKTPS 9600001-7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown