BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER KIT, GASTROSTOMY FEEDING TUBE, 18FR DILATOR

    MDR report key: 17765800 · Received September 18, 2023

    Report

    Report Number
    9611594-2023-00135
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 18, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    UDI-DI
    10680651984316
    PMA / PMN Number
    K080253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 15-SEP-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 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. H3 OTHER TEXT : NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED " AFTER [THE] GASTROSTOMY OPERATION WAS PERFORMED, IT BLED FROM THE POSTERIOR GASTRIC WALL. THOUGH INSUFFLATION TO PATIENT'S STOMACH [WAS PERFORMED] THE DISTANCE BETWEEN STOMACH WALL AND ABDOMINAL WALL...DID NOT GET CLOSER. [THE CLINICIAN] PULLED [THE] STOMACH WITH FUNADA GASTROPEXY DEVICE USING FORCEPS UNDER LAPAROSCOPE." WHEN THE "DILATOR WAS USED, IT TOUCHED THE POSTERIOR GASTRIC WALL AND IT BLED FROM THERE. NOW THE PATIENT IS RECOVERING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268179 INTRODUCER KIT, GASTROSTOMY FEEDING TUBE, 18FR DILATOR DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. 98431 UNKNOWN 10680651984316

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other