BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAGOWN FLEXNECK YELLOW XLARGE

    MDR report key: 23706737 · Received December 3, 2025

    Report

    Report Number
    MW5179822
    Event Type
    Injury
    Date Received
    December 3, 2025
    Report Date
    December 1, 2025
    Manufacturer
    UNKNOWN
    Product Code
    OEA
    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
    2829315 VERSAGOWN FLEXNECK YELLOW XLARGE NON-SURGICAL ISOLATION GOWN OEA UNKNOWN 17-9962-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown