BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN, DH EF PERC PLACEMENT PRODUCTS

    MDR report key: 15523752 · Received October 1, 2022

    Report

    Report Number
    9611594-2022-00121
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 30, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KGC
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    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 27 SEP 2022 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, A MIC-KEY BUTTON WAS PLACED IN THE PATIENT AND ONE OF THE 3 T-SHAPED METAL 'ANCHORS' USED TO PULL THE STOMACH WALL UP AGAINST THE ABDOMINAL WALL DID NOT STAY IN THE STOMACH BUT FOLLOWED THE INTRODUCER UP AND STUCK IN THE STOMACH WALL UNDER THE MUCOSA. THE ANCHOR REPORTEDLY WAS, ¿SMALL AND DOES NOT INTERFERE¿, WILL REMAIN IN THE PATIENT¿S BODY; AND IF IT NEEDS TO BE REMOVED MUST BE [REMOVED] SURGICALLY. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 13SEP2022 REPORTED, ¿THE PATIENT IS DOING WELL¿, HAS LEFT THE HOSPITAL AND USES THE GASTROSTOMY FOR TUBE FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383906 UNKNOWN, DH EF PERC PLACEMENT PRODUCTS DH EF PERC PLACEMENT PRODUCTS KGC AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female