BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE NATURAL CLASSIC STYLE SURGICAL FACE MASK

    MDR report key: 35699 · Received July 12, 1996

    Report

    Report Number
    35699
    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
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANESTHESIA RESIDENT AFTER DONNING HER FACE MASK COMPLAINED OF FACIAL SORENESS AND BURNING. UNDER THE MASK, IN THE PERIORAL AREA, WHERE THE MASK CONTACTED THE FACE, THERE WAS A LARGE ERYTHEMATOUS LESION, SORE TO TOUCH. MASK WAS REMOVED AND TOPICAL CORTICOSTEROID CREAM APPLIED WITH SOME RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE NATURAL CLASSIC STYLE SURGICAL FACE MASK MASK FXX TECHNOL MEDICAL PRODUCTS, INC. 80-410 6158T090E

    Patients

    Seq Age Sex Outcome Treatment
    1 *