BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENTASWAB,W/DENTIFRICE,20PACK 2 DISPENSER

    MDR report key: 6670670 · Received June 27, 2017

    Report

    Report Number
    8030647-2017-00060
    Event Type
    Death
    Date Received
    June 27, 2017
    Date of Event
    June 3, 2017
    Report Date
    October 24, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT IS AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 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 (B)(6) HEALTH. (B)(6) 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE ORAL SWAB WAS SWALLOWED BY A PATIENT. ADDITIONAL INFORMATION WAS REPORTED ON (B)(6) 2017 IN AN EMAIL FROM THE CUSTOMER ON (B)(6) 2017 THAT THE PATIENT PASSED AWAY WITH NO OTHER INFORMATION AND UNKNOWN WHAT CAUSED THE DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT STATES, THE FAMILY PROVIDED NO ADDITIONAL DETAILS REGARDING THE CAUSE OF DEATH OF THE PATIENT. NO RESPONSE FROM ADDITIONAL FOLLOW UP WAS RECEIVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 THAT STATES, "PER CONVERSATION WITH THE PATIENTS DAUGHTER: THE PATIENT WAS TERMINALLY ILL AND BEING PLACED ON HOSPICE FOR LATE STAGE PARKINSON'S, ALZHEIMER'S, AND INFECTION. THE PATIENT'S DAUGHTER HAD REQUESTED THE NURSING STAFF NOT TO USE ORAL CARE IN THE PATIENT'S MOUTH BUT THEY DID AND THE PATIENT (NOT ON VENTILATOR) BIT DOWN AND BROKE OFF THE END OF THE ORAL CARE SWAB AND SWALLOWED IT. THERE WAS NO IMMEDIATE IMPACT ON THE PATIENT DUE TO SWALLOWING THE END OF THE SWAB AND NO REPORTED RESPIRATORY CONSEQUENCES. THE PATIENT DID DIE A FEW DAYS LATER BUT NOT UNEXPECTEDLY DUE TO UNDERLYING HEALTH ISSUES." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449918 DENTASWAB,W/DENTIFRICE,20PACK 2 DISPENSER VAP ORAL CARE PRODUCTS KXF HALYARD HEALTH 12249 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death