BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SURGICAL GOWN

    MDR report key: 1971342 · Received January 27, 2011

    Report

    Report Number
    9680646-2011-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS; HOWEVER, STERILIZATION OF THE PRODUCT WAS NOT DOCUMENTED. A VOLUNTARY RECALL OF IMPACTED PRODUCTS WAS INITIATED ON (B)(6) 2010 AND IS ONGOING ((B)(4)). INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS.

    Description of Event or Problem · 1

    CLINICS OR CONTACT INDICATED THAT ULTRA GOWNS THAT WERE POTENTIALLY NON-STERILE AND THE SUBJECT OF A RECALL HAD BEEN WORN BY CLINICIANS DURING AN UNDISCLOSED QUANTITY OF SURGICAL PROCEDURES. NO IMPACT TO PATIENTS WAS IDENTIFIED. THIS PRODUCT INCIDENT IS DOCUMENTED IN (B)(4) AND IDENTIFIED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SURGICAL GOWN ULTRA GOWN FYA KIMBERLY-CLARK HEALTH CARE AH0319B,AH0320B

    Patients

    Seq Age Sex Outcome Treatment
    1