BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICARE VINYL GLOVES

    MDR report key: 276803 · Received May 9, 2000

    Report

    Report Number
    2914024-2000-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Date of Event
    April 13, 2000
    Report Date
    May 8, 2000
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    LYZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE WORKER HAD BLOOD ON WRIST AFTER REMOVING GLOVE. WHILE NO IMMEDIATE HEALTH CONCERN, THERE IS THE POTENTIAL THAT THE HEALTHCARE PROVIDER MAY HAVE BEEN IN CONTACT WITH A BLOODBORNE PATHOGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSICARE VINYL GLOVES NON-STERILE POWDERED MEDICAL EXAMINATION GLOVES LYZ MAXXIM MEDICAL NA 92351Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other