BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL PACK

    MDR report key: 5569593 · Received April 12, 2016

    Report

    Report Number
    5569593
    Event Type
    Malfunction
    Date Received
    April 12, 2016
    Date of Event
    January 27, 2016
    Report Date
    March 3, 2016
    Manufacturer
    HALYARD
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL INTERVENTION, CALLED TO ROOM AND WAS GIVEN A GOWN WORN BY SURGEON. PATIENT'S BODY FLUIDS SOAKED THROUGH THE SLEEVE OF THE GOWN FROM GLOVE CUFF TO APPROXIMATELY THREE INCHES ABOVE CUFF. SURGICAL TECHNICIAN SAID THAT THE STRIKE THROUGH BEGAN DISTAL TO THE GLOVE CUFF AND WORKED DOWN TO CUFF. GOWN BAGGED, LABELED, AND GIVEN TO SUPPLY CHAIN TO BE RETURNED TO MANUFACTURER FOR INVESTIGATION. THIS WAS THE SECOND SUCH CASE OF STRIKE THROUGH ON A AAMI 4 GOWN-DESIGNED FOR USE ON CASES WITH HIGH VOLUME BODILY FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224980 BOWEL PACK GOWN, SURGICAL FYA HALYARD 90257281

    Patients

    Seq Age Sex Outcome Treatment
    1