BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL CARE KIT,W/MOIST,PEROXIDE

    MDR report key: 6404291 · Received March 14, 2017

    Report

    Report Number
    8030647-2017-00032
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    February 16, 2017
    Report Date
    March 14, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT IS AVAILABLE BUT HAS NOT BEEN RETURNED YET FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M6284A603, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME - CORRECTION, KXF. ALL INFORMATION REASONABLY KNOWN AS OF 30MAR2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THERE WERE THREE SWABS THAT BROKE DURING USE. THERE WAS NO INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186926 ORAL CARE KIT,W/MOIST,PEROXIDE VAP ORAL CARE PRODUCTS KXF HALYARD HEALTH 12260 M6284A603

    Patients

    Seq Age Sex Outcome Treatment
    1