BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAGOWN FLEXNECK YELLOW XLARGE

    MDR report key: 23672153 · Received November 28, 2025

    Report

    Report Number
    MW5179489
    Event Type
    Injury
    Date Received
    November 28, 2025
    Report Date
    November 24, 2025
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FYC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A CLINICAL MANAGER REPORTED TO (B)(6) VIA FAX THAT AN EMPLOYEE EXPERIENCED ITCHY SKIN, RASH, AND HIVES ON BOTH ARMS WHILE WEARING THESE GOWNS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3476 VERSAGOWN FLEXNECK YELLOW XLARGE GOWN, ISOLATION, SURGICAL FYC AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown