BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR

    MDR report key: 9010123 · Received September 12, 2019

    Report

    Report Number
    9611594-2019-00171
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    June 25, 2019
    Report Date
    December 23, 2019
    Manufacturer
    AVANOS MEDICAL INC
    Product Code
    KNT
    UDI-DI
    10680651442922
    PMA / PMN Number
    K842076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 13 DEC 2019 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 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 · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 11 SEP 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 "ON CLINICAL EXAMINATION, ERYTHEMA AROUND THE GASTROSTOMY ORIFICE WITH INDURATION SUGGESTIVE OF A WALL ABSCESS. WALL ULTRASONOGRAPHY FOUND SUBCUTANEOUS INFILTRATION BUT WITHOUT VISUALIZED ABSCESS." PRODUCT WAS IN USE FOR TWO MONTHS. ANTIBIOTICS WERE REQUIRED AS MEDICAL TREATMENT. PATIENT'S CURRENT STATUS WAS LISTED AS "HE'S FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803856 MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC 8100-16LV AA8288D20 10680651442922

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other