BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN FEEDING TUBE

    MDR report key: 8790734 · Received July 15, 2019

    Report

    Report Number
    9611594-2019-00139
    Event Type
    Death
    Date Received
    July 15, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 15, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT 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 15 JUL 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. 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 THAT THE PATIENT DIED; NO EXPLANATION WAS GIVEN BY THE RETIREMENT HOME. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE CAUSE OF THE DEATH OR IF AN AUTOPSY WAS PERFORMED. ACCORDING TO THE DISTRIBUTOR, "THE PATIENT HAD A MIC-KEY BUTTON TUBE PLACEMENT ON (B)(6) 2019 AND PATIENT DIED ON (B)(6) [2019]." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582082 UNKNOWN FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death DUODOPA