BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE

    MDR report key: 17164931 · Received June 20, 2023

    Report

    Report Number
    9611594-2023-00086
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 19, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    10680651984316
    PMA / PMN Number
    K080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ALL INFORMATION REASONABLY KNOWN AS OF 13 JUN 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED ¿AFTER FIXING THE GASTRIC WALL WITH GASTROPEXY, THE T-FASTENER CAME OUT FROM THE BODY SURFACE SEVERAL WEEKS AFTER THE OPERATION. WHEN THE T FASTENER CAME OUT OF THE BODY SURFACE, IT WAS REMOVED, AND THERE WAS NO PARTICULAR HEALTH HAZARD. NECESSITY OF REPLACEMENT: UNNECESSARY.¿ NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462908 INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98431 UNKNOWN 10680651984316

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown