BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM

    MDR report key: 20990510 · Received December 20, 2024

    Report

    Report Number
    3011270181-2024-00134
    Event Type
    Death
    Date Received
    December 20, 2024
    Date of Event
    November 23, 2024
    Report Date
    February 17, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD AND UDI ARE IN-PROGRESS. HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/DETAIL.CFM?MDRFOI__ID=20841907&PC=KNT. ALL INFORMATION REASONABLY KNOWN AS OF 17 FEB 2026 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.

    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; THEREFORE, THE UDI-PI IS UNAVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, B6. ALL INFORMATION REASONABLY KNOWN AS OF 20 JAN 2025 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.

    Description of Event or Problem · 0

    FDA MAUDE MW5163063 RECEIVED ON 23JAN2026, ¿CORGRIP SR NASAL BRIDLE WAS BEING TRIALED BY TRAINED CORPAK INSERTION STAFF. A 55 Y/O M WITH HISTORY OF UROTHELIAL CANCER WITH METASTATIC HAD CORPAK INSERTED USING THE CORGRIP SR DEVICE (B)(6) 2024. PATIENT WAS IN RESPIRATORY DISTRESS (B)(6) 2024 AND RT (RESPIRATORY THERAPIST) SUCTIONED BLOOD FOR NASAL/ORAL AIRWAY. ENT (EAR, NOSE, AND THROAT) WAS IMMEDIATELY CONSULTED WHO CAME TO BEDSIDE AND REMOVED CLOTS FROM NASAL PASSAGEWAY. PATIENT DID NOT HAVE ANY CONTRAINDICATIONS TO CORPAK INSERTION. PATIENT SUBSEQUENTLY EXPIRED (B)(6) 2024. CONCERN THAT SHAPE OF CORGRIP SR NASAL BRIDLE CAUSED OROPHARNYX BLEEDING.¿

    Description of Event or Problem · 0

    IT WAS REPORTED, ¿ON FRIDAY (B)(6)2024, AN ONCOLOGY PATIENT REQUIRED THE INSERTION OF A CORTRAK TUBE, AND A CORGRIP SR WAS PLACED TO RETAIN THE TUBE. THE CORGRIP SR WAS PLACED FIRST PRIOR TO THE TUBE INSERTION- NO COMPLICATIONS OR BLEEDING OCCURRED WITH THE INSERTION. THE CORTRAK TUBE WAS THEN INSERTED. THE PATIENT WAS EXPERIENCING NAUSEA, SO THE TUBE INSERTION WAS PAUSED- TUBE WAS WITHDRAWN AND NAUSEA MEDICATION WAS ADMINISTERED. WHEN THE PATIENT WAS READY, THE CORTRAK TUBE PLACEMENT RESUMED. THE TUBE WAS SUCCESSFULLY PLACED WITHOUT COMPLICATIONS. THROUGH A NASAL BRIDLE INSERTION AND 2 CORTRAK ATTEMPTS, NO NASAL BLEEDING OCCURRED. THE CLINICAL NURSE SPECIALIST INFORMED ME THAT THE FOLLOWING OCCURRED OVER THE WEEKEND: STARTING SATURDAY MORNING, THE PATIENT WAS RAPID RESPONDED TO TWICE FOR A NOSEBLEED AND MOVED TO THE ICU. THE PATIENT ULTIMATELY PASSED AWAY. RISK MANAGEMENT IS NOW REVIEWING THE CASE AND FOUND INFORMATION RELATED TO THE CORGRIP SR NASAL BRIDLE, REPORTED BY ENT. AT SOME POINT OVER THE WEEKEND, ENT WAS CONSULTED FOR THE NOSEBLEED AND COMPLETED A RHINOSCOPY. IT WAS REPORTED THAT THE BLEEDING WAS COMING FROM A TEAR IN THE RIGHT SEPTUM. THE ENT TEAM NOTED THAT THE CONTRIBUTING FACTORS COULD HAVE POTENTIALLY BEEN THE TRIANGLE DESIGN OF THE NASAL BRIDLE, OR DRY MUCUS MEMBRANES.¿ PER ADDITIONAL INFORMATION RECEIVED ON 06DEC2024, ¿THIS WAS ANTERIOR RHINOSCOPY MEANING I USED A NASAL SPECULUM, AND I SAW THE SPECIFIC BLEED BELOW THE BRIDLE WHICH I PUSHED DOWN.¿

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED ON 12DEC2024, THE PATIENT¿S ADMITTING DIAGNOSIS WAS ¿COMPLICATED UTI.¿ PATIENT WAS ADMITTED ON (B)(6) 2024. DURING ADMISSION PATIENT RECEIVED ANTIBIOTICS AND NUTRITION FOR SEVER MALNUTRITION. RHINOSCOPY WAS PERFORMED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204176 CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM DH CPK CORGRIP TUBE RETENTION KNT AVANOS MEDICAL INC. 26-010 C2460494A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death| O