BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICKEY GTUBE LP,24FR,3.0CM,1

    MDR report key: 19872183 · Received July 31, 2024

    Report

    Report Number
    9611594-2024-00148
    Event Type
    Injury
    Date Received
    July 31, 2024
    Report Date
    October 3, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF, 30-JUL-2024, 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. 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 AVANOS MEDICAL, INC. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF, 30-AUG-2024, 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. 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 AVANOS MEDICAL, INC. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, GRANULOUS TISSUE WAS GROWING AROUND FEEDING TUBE. THE NURSE PRACTIONER (N.P.) HAS HAD TO BURN OFF THE TISSUE USING SILVER NITRATE STICKS. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT (ED) ON (B)(6) 20274 "DUE TO STOMA SITE IRRITATION AND BLEEDING; TUBE WAS SWITCHED OUT."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 06-AUG-2024 STATING THE "HOSPITAL KEPT TUBES SO SAMPLE UNAVAILABLE. ALSO REPORTED THAT A 24 F, 2.3 CM TUBE WAS PLACED INSTEAD, WITH BALLOON FILLED AT APPROXIMATELY 5 ML. STATES SEEMS TO HAVE RESOLVED THE ISSUE, AND THAT THE TISSUE GROWS 'WHEN THERE IS A GAP'; DOESN'T SEEM TO BE HAPPENING WITH TIGHTER FIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912685 MICKEY GTUBE LP,24FR,3.0CM,1 DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0120-24-3.0 30282300

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Other