BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PEG INITIAL PLACEMENT PRODUCT

    MDR report key: 15166750 · Received August 4, 2022

    Report

    Report Number
    2026095-2022-00088
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    June 15, 2022
    Report Date
    August 4, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 03-AUG-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, 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 THE PATIENT WOKE YESTERDAY MORNING TO FIND HIS PEJ (PERIPHERAL EPIGASTRIC JEJUNOSTOMY) TUBE DISLODGED, HE IMMEDIATELY WENT TO THE HOSPITAL AND HAD A NEW PEJ INSERTED. THE PATIENT STATED HE HAD "SEVERE GASTRIC LEAKAGE FROM DIRECT PEJ SITE THAT IS CAUSING HIM DISTRESS TO MANAGE." HE STATED THAT HE HAD TO CHANGE THE PAD DRESSING EVERY HOUR AND ITS SOAKED THROUGH. THE PATIENT HAS ONGOING ISSUES WITH STOMA LEAKAGE. THE PATIENT, "HAS BEEN FOLLOWED UP BY MEDICAL TEAM WITH NIL FURTHER ADVICE PROVIDED FROM PREVIOUS REVIEWS. STATES MODERATE AMOUNT OF CLEAR FLUID LEAKING FROM SITE. AREA AROUND STOMA IS EXCORIATED. HE IS ON INCREASED AMOUNTS OF MOVICOL AND BOWELS MOVING WELL AND REGULARLY. HE IS KEEPING THE FIXATION DEVICE SECURE TO ABDOMEN. HE IS APPLYING SAVLON TO EXCORIATED AREA." ADDITIONAL INFORMATION RECEIVED STATED PATIENT WAS FOLLOWED-UP WITH A HOME VISIT AFTER REPORTED EXCESSIVE STOMA DISCHARGE POST NEW PEJ INSERTION AFTER PEJ DISLODGING LAST WEEK. REVIEWED 21-JUN-2022 BY GENERAL PRACTITIONER AND PRACTICE NURSE. AWAITING PATHOLOGY RESULTS. DRESSING MANAGEMENT AND APERIENT ADVICE GIVEN WITH FURTHER REVIEW ADVISED IF NOT RESOLVED. PATIENT HAS BEEN TREATED SUCCESSFULLY FOR CONSTIPATION AND WITH ANTIBIOTICS FOR RED PAINFUL STOMA (UNSURE WHICH TYPE). HAS HAD A NEGATIVE WOUND SWAB. ADVISED TO SEEK MEDICAL OPINION REGARDING LEAKING, POTENTIALLY FROM THE SURGEON WHO INSERTED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722109 UNKNOWN PEG INITIAL PLACEMENT PRODUCT DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male