BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCOOL

    MDR report key: 3151608 · Received April 17, 2013

    Report

    Report Number
    3151608
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 17, 2013
    Manufacturer
    KIMBERLY CLARK
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON DONNED DISPOSABLE STERILE GOWN AND STARTED CASE. MOMENTS LATER, THE CIRCULATOR NOTED THAT SEVERAL SMALL HOLES HAD SPONTANEOUSLY APPEARED ON THE FRONT OF THE SURGICAL GOWN. GOWN WAS REMOVED AND HELD UP TO THE LIGHT. STAFF IDENTIFIED MULTIPLE AREAS ON THE FRONT OF THE GOWN WHERE THE MATERIAL WAS THIN AND WEAK.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SURGICAL COVER GOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165585 MICROCOOL SURGICAL COVER GOWN (STERILE, DISPOSABLE) FYA KIMBERLY CLARK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES