BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC- HANDI-BIN

    MDR report key: 3288098 · Received August 14, 2013

    Report

    Report Number
    9680646-2013-00010
    Date Received
    August 14, 2013
    Report Date
    July 18, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS AN INCOMPLETE 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, ¿THE CUSTOMER REPORTS A HOLE WAS NOTICED IN THE GOWN UPON OPENING THE TRAY PRIOR TO USE.¿ 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
    390642 ULTRA SURGICAL GOWN WITH POLYPROPYLENE FABRIC- HANDI-BIN SURGICAL GOWN FYA KIMBERLY-CLARK HEALTH CARE AH305220

    Patients

    Seq Age Sex Outcome Treatment
    1