BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENT MEDICAL

    MDR report key: 374908 · Received January 22, 2002

    Report

    Report Number
    1065445-2002-00007
    Event Type
    Injury
    Date Received
    January 22, 2002
    Report Date
    January 22, 2002
    Manufacturer
    LRC HOSPITAL PRODUCTS, SDM
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, A HEALTH CARE WORKER DEVELOPED A LATEX ALLERGY WHILE WORKING IN VARIOUS HOSPITALS. SSL AMERICAS, INC. WAS NOTIFIED OF THE ALLEGED EVENTS THROUGH A PROCESS OF LITIGATION INVOLVING MANY COMPANIES. IT IS UNCLEAR THAT DEVICE WAS USED OR CAUSED ANY INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENT MEDICAL LATEX GLOVES LYY LRC HOSPITAL PRODUCTS, SDM UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention INFO UNKNOWN