BEUDAMED
    FDA Adverse Event Summary report: N

    MICROCOOL SURGICAL GOWN XL

    MDR report key: 3222432 · Received July 12, 2013

    Report

    Report Number
    9680646-2013-00007
    Date Received
    July 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT.THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT.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. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "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." 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 DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322229 MICROCOOL SURGICAL GOWN XL SURGICAL GOWN FYA KIMBERLY-CLARK HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1