BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATION GOWN LARGE

    MDR report key: 17536690 · Received August 12, 2023

    Report

    Report Number
    MW5143573
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    September 23, 2020
    Manufacturer
    UNKNOWN
    Product Code
    OEA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CLINIC REGISTERED NURSE (RN) CONTACTED REPORTED VIA EMAIL THAT THEY FOUND SMALL BUG/ANT WITH RED HEAD ON THE UNOPENED PACKAGE OF YELLOW GOWNS, AN EMPLOYEE GOT BIT AND HAD SWOLLEN, ITCHY RED RAISED BUMPS. (B)(4), (B)(4). 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
    1084959 ISOLATION GOWN LARGE NON-SURGICAL ISOLATION GOWN OEA UNKNOWN 17-5115-0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown