BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC AND TOWEL

    MDR report key: 3287872 · Received August 14, 2013

    Report

    Report Number
    9680646-2013-00008
    Date Received
    August 14, 2013
    Report Date
    July 17, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. ONE SAMPLE WAS RETURNED. THE GOWN WAS REVIEWED AND SHOWED A TEAR ON THE FRONT OF THE GOWN. TEAR APPEARS CAUSED BY A NAIL OR AS IF THE GOWN WAS TRAPPED ON A SHARP EDGE. 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.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿A HOLE WAS FOUND IN THE FRONT OF THE GOWN WHILE DONNING ¿ 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
    393167 ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC AND TOWEL SURGICAL GOWN FYA KIMBERLY-CLARK HEALTH CARE H304016105

    Patients

    Seq Age Sex Outcome Treatment
    1