BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO SURGEONS GLOVE

    MDR report key: 10395253 · Received August 12, 2020

    Report

    Report Number
    10395253
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    SVS LLC
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE PULLED A GLOVE FROM THE BOX OF GLOVES IN THE PATIENT ROOM AND THE GLOVE HAD BLACK DEBRIS ON IT. WHEN SHE WENT FOR ADDITIONAL GLOVES IN THE SAME BOX A CLUMP OF BLACK DEBRIS WAS FOUND. MANY OF THE GLOVES IN THE BOX HAVE BLACK DEBRIS ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861874 PREMIERPRO SURGEONS GLOVE SURGEON'S GLOVES KGO SVS LLC CZJ 04-02

    Patients

    Seq Age Sex Outcome Treatment
    1