BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN GOWN

    MDR report key: 5837310 · Received August 1, 2016

    Report

    Report Number
    5837310
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNERGY HEALTH AST, LLC
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR JUST FINISHED UP WITH A SURGERY AND TOOK OFF HIS GOWN; THE PATIENT'S BLOOD HAD SEEPED THROUGH THE GOWN ONTO HIS FOREARMS. THE GOWN WAS DEFECTIVE AND SHOULD HAVE NOT CAUSED BLOOD TO GET ON HIS SKIN. THE GOWN THAT MD WORE WAS A LARGE STD GOWN. HE NOTICED THE BLOOD RIGHT WHEN HE TOOK OFF HIS GOWN AND WE TOOK A PICTURE OF HIS FOREARMS. THIS ALSO BREAKS STERILIZATION IF THE GOWNS AREN'T PROTECTING THE PHYSICIANS' SKIN FROM TOUCHING THE STERILE FIELD. THIS COULD HAVE BEEN PREVENTED IF THE MANUFACTURER OF THE GOWNS ARE AWARE THAT THE GOWNS ARE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490123 GREEN GOWN GOWN, SURGICAL FYA SYNERGY HEALTH AST, LLC 1003D

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR