BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC AND TOWEL

    MDR report key: 3314621 · Received August 28, 2013

    Report

    Report Number
    9680646-2013-00009
    Date Received
    August 28, 2013
    Date of Event
    July 26, 2013
    Report Date
    July 30, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE SAMPLE WAS RETURNED AND EVALUATION IDENTIFIED THAT THE BOTTOM AND TOP LAYERS OF THE PACKAGE WERE MISALIGNED. NO ADDITIONAL SIMILAR COMPLAINTS INVOLVING THIS CODE HAVE BEEN REPORTED, 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, ¿THE NURSE OPENED THE STERILE GOWN BUT THE BOTTOM OF THE PACKAGE WAS ALREADY OPENED AND NOT SEALED.¿ 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
    424491 ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC AND TOWEL SURGICAL GOWN FYA KIMBERLY-CLARK HEALTH CARE AH3109B

    Patients

    Seq Age Sex Outcome Treatment
    1