BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO COOL KC 400, BREATHABLE SPECIALTY GOWN

    MDR report key: 1660083 · Received April 15, 2010

    Report

    Report Number
    9680646-2010-00001
    Event Type
    Injury
    Date Received
    April 15, 2010
    Report Date
    March 24, 2010
    Manufacturer
    AVENT DE HONDRUAS S.A. DE C.V
    Product Code
    FYA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RECEIVED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL INFORMATION WAS RECEIVED AT THIS TIME. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. GOWN WAS NOT RETURNED TO KIMBERLY-CLARK.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A COMPLAINT INDICATING THAT A SURGEON WHILE WEARING THE KC 400 GOWN DURING A SURGERY DEVELOPED A HOLE IN THE GOWN. PATIENT IS REPORTED TO HAVE DEVELOPED A POST OPERATIVE INFECTION. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATA BASE AS RECORD (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO COOL KC 400, BREATHABLE SPECIALTY GOWN KC 400 MICRO COOL GOWN FYA AVENT DE HONDRUAS S.A. DE C.V

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other