BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD RITMED ASSUREWEAR VERSAGOWN

    MDR report key: 17692706 · Received September 5, 2023

    Report

    Report Number
    MW5145240
    Event Type
    Injury
    Date Received
    September 5, 2023
    Report Date
    September 1, 2023
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FYC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GOWN, ISOLATION, WHITE, XLA USER FACILITY REPORTED THAT THE GOWN GAVE A NURSE A RASH. 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
    1639140 AMD RITMED ASSUREWEAR VERSAGOWN GOWN, ISOLATION, SURGICAL FYC AMD MEDICOM INC. A69982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown