BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL GOWNS

    MDR report key: 12655757 · Received October 19, 2021

    Report

    Report Number
    12655757
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 14, 2021
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NARRATIVE FROM STAFF: DURING SETUP THE CERTIFIED SURGICAL TECHNOLOGIST (CST) ASSIGNED TO THE CASE GOWNED USING OUR DISPOSABLE SURGICAL GOWN. AFTER GOWNING THE STAFF IN THE ROOM NOTICED A DEAD FLY ON THE FLOOR RIGHT WHERE THE CST GOWNED. THIS FLY WAS NOT THERE AT THE START OF THE DAY AND IT IS BELIEVED THAT THIS FLY WAS IN THE SURGICAL GOWN THAT HAD BEEN OPENED. THE CST REMOVED THE GOWN AND RESCRUBBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555569 SURGICAL GOWNS GOWN, SURGICAL FYA DYNAREX CORPORATION 8193 47776

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA