BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DH EF BALLOON TUBES PRODUCTS

    MDR report key: 10158379 · Received June 16, 2020

    Report

    Report Number
    9611594-2020-00100
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 16, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 15 JUN 2020 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 AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. 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 AVANOS MEDICAL INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S "STOMA SITE [WAS] VERY RED, FEW BLISTERS NOTICED, STOMA LEAKING, PATIENT IS DRESSING THE SITE TWICE DAILY." ADDITIONAL INFORMATION RECEIVED 26-MAY-2020 INDICATED THAT A PRESCRIPTION MEDIPORE DRESSING WAS BEING USED. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621368 UNKNOWN DH EF BALLOON TUBES PRODUCTS DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention