BEUDAMED
    FDA Adverse Event Summary report: N

    MEDICAL GOWN AND MASK

    MDR report key: 13771 · Received May 31, 1994

    Report

    Report Number
    MW4000402
    Date Received
    May 31, 1994
    Report Date
    May 4, 1994
    Manufacturer
    SAFETEC OF AMERICA
    Product Code
    LYU
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE COMPANY IS PROMOTING PRODUCTS AS NOT NEEDING 510K APPLICATIONS, WHEN IN FACT THEY DO. GOWNS DO NOT HAVE 510K APPLICATIONS AND MASKS ARE NOT UP TO SPECIFICATIONS. THE COMPANY IS TELLING CLIENTS THAT THE PRODUCTS MEET OSHA STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL GOWN AND MASK LYU SAFETEC OF AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 *