BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LITE ONE

    MDR report key: 35701 · Received July 12, 1996

    Report

    Report Number
    35701
    Event Type
    Injury
    Date Received
    July 12, 1996
    Report Date
    June 30, 1996
    Manufacturer
    TECHNOL MEDICAL PRODUCTS, INC.
    Product Code
    FXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OR TECH REPORTED FACE RASH AND ITCHING AFTER APPLYING A FACE MASK. TREATED WITH STEROID CREAM WITH RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LITE ONE SURGICAL FACE MASK FXX TECHNOL MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO