BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTOMY PACK IV

    MDR report key: 2960094 · Received February 13, 2013

    Report

    Report Number
    3005997949-2013-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE, WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. NO SIMILAR COMPLAINTS FOR THE PRODUCT AND LOT # REFERENCED IN THIS REPORT HAVE BEEN RECEIVED BY KIMBERLY-CLARK. 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 FROM (B)(6) STATING, "THE PRODUCT SET IS OPEN ON THE SIDE FROM THE PACKAGE. THE SEALING SUTURE IS OPEN." THERE WAS NO PATIENT CONTACT. 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
    63036 LITHOTOMY PACK IV STERILE SURGICAL PACK KKX KIMBERLY-CLARK HEALTH CARE AC2095D

    Patients

    Seq Age Sex Outcome Treatment
    1